Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves

ABSTRACT

A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/476,215, filed Sep. 15, 2021, entitled “Delivery and RetrievalDevices and Method for Side-Deliverable Transcatheter ProstheticValves,” which is a divisional of U.S. patent application Ser. No.17/193,946, filed Mar. 5, 2021, entitled “Delivery and Retrieval Devicesand Method for Side-Deliverable Transcatheter Prosthetic Valves,” nowU.S. Pat. No. 11,179,239, which is a continuation of InternationalPatent Application No. PCT/US2020/047162, filed Aug. 20, 2020, entitled“Delivery and Retrieval Devices and Method for Side-DeliverableTranscatheter Prosthetic Valves,” which claims priority to and thebenefit of U.S. Provisional Patent Application No. 63/038,807, filedJun. 13, 2020, entitled “Retrieval Device and Method forSide-Deliverable Transcatheter Prosthetic Valves;” U.S. ProvisionalPatent Application No. 63/027,345, filed May 19, 2020, entitled“Side-Deliverable Transcatheter Prosthetic Valves and Method forDelivering and Anchoring the Same;” U.S. Provisional Patent ApplicationNo. 62/891,964, filed Aug. 27, 2019, entitled “Wrap Around Anchor Armand Catheter Delivery System for Side-Delivered Transcatheter HeartValve Prosthesis;” and U.S. Provisional Patent Application No.62/889,327, filed Aug. 20, 2019, entitled “Loader System forSide-Delivered Transcatheter Heart Valve Prosthesis,” the disclosure ofeach of which is incorporated herein by reference in its entirety.

BACKGROUND

The embodiments described herein relate generally to transcatheterprosthetic valves and more particularly, to delivery and/or retrievaldevices and methods for side-deliverable transcatheter prostheticvalves.

Prosthetic heart valves can pose challenges for delivery, deployment,and/or retrieval within a heart, particularly for delivery by cathetersthrough the patient's vasculature rather than through a surgicalapproach. Delivery of traditional transcatheter prosthetic valvesgenerally includes compressing the valve in a radial direction andloading the valve into a delivery catheter such that a central annularaxis of the valve is parallel to a lengthwise or longitudinal axis ofthe delivery catheter. The valves are deployed from an end of thedelivery catheter and expanded outwardly in a radial direction from thecentral annular axis. The expanded size (e.g., diameter) of traditionalvalves, however, can be limited by the internal diameter of the deliverycatheter. The competing interest of minimizing delivery catheter sizepresents challenges to increasing the expanded diameter of traditionalvalves (e.g., trying to compress too much material and structure intotoo little space). Moreover, the orientation of the traditional valvesduring deployment can create additional challenges when trying to alignthe valves with the native valve annulus.

Some transcatheter prosthetic valves can be configured for side and/ororthogonal delivery, which can allow for an increase in an expandeddiameter of the side-delivered valve relative to traditional valves. Forexample, in a side (orthogonal) delivery, the valve can be placed in acompressed or delivery configuration and loaded into a delivery cathetersuch that a central annular axis of the valve is substantiallyperpendicular and/or orthogonal to a lengthwise or longitudinal axis ofthe delivery catheter. More particularly, the valve can be compressedaxially (e.g., along the central annular axis) and laterally (e.g.,perpendicular to each of the central annular axis and a longitudinalaxis of the valve), and uncompressed or elongated longitudinally (e.g.,in a direction parallel to the lengthwise or longitudinal axis of thedelivery catheter). The compressed valve (e.g., the valve in a deliveryconfiguration) can be loaded into the delivery catheter, advancedthrough a lumen thereof, and deployed from the end of the deliverycatheter. Moreover, the side-delivered valve is generally in a desiredorientation relative to the native valve annulus when deployed from theend of the delivery catheter.

In some implementations, however, challenges associated with compressingthe side-deliverable valve and/or the loading of the valve into adelivery system may persist. In addition, in some instances, it may bedesirable to retrieve or at least partially retrieve the valve afterdeployment of valve from the end of the delivery catheter.

Accordingly, a need exists for delivery and/or retrieval devices andmethods for side-deliverable transcatheter prosthetic valves.

SUMMARY

The embodiments described herein are directed to side-deliverableprosthetic valves and devices and/or methods for delivering and/orretrieving the side-deliverable prosthetic valves. In some embodiments,a delivery system for side-delivery of a transcatheter prosthetic valveincludes a compression device, a loading device, and a delivery device.The compression device defines a lumen that extends through a proximalend and a distal end, with a perimeter of the lumen at the proximal endbeing larger than a perimeter of the lumen of the distal end. Theloading device defines a lumen that extends through a proximal end and adistal end thereof. A perimeter of the lumen of the loading device issubstantially similar to the perimeter of the lumen at the distal end ofthe compression device. The proximal end of the loading device iscoupleable to the compression device and the distal end of the loadingdevice includes a first gate that is movable between an open state and aclosed state in which the first gate at least partially occludes thelumen of the loading device. The delivery device has a handle and adelivery catheter extending distally from the handle. The handle and thedelivery catheter collectively define a lumen that extends through thedelivery device. A perimeter of the lumen of the delivery device issubstantially similar to the perimeter of the lumen of the loadingdevice. A proximal end of the handle is coupleable to the distal end ofthe loading device and includes a second gate that is movable between anopen state and a closed state in which the second gate at leastpartially occludes the lumen of the delivery device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are front view schematic illustrations of aside-delivered transcatheter prosthetic heart valve (also referred toherein as “prosthetic valve”), according to an embodiment, and shown inan expanded configuration and a compressed configuration, respectively.

FIGS. 1C and 1D are top view schematic illustrations of the prostheticvalve of FIGS. 1A and 1B and shown in the expanded configuration and thecompressed configuration, respectively.

FIG. 1E is a schematic illustration of the prosthetic valve of FIGS.1A-1D deployed within an annulus of a native heart valve.

FIGS. 2A and 2B are side-view schematic illustrations of a prostheticvalve in a first configuration and a second configuration, respectively,according to an embodiment.

FIGS. 2C and 2D are a bottom-view schematic illustration and a side-viewschematic illustration of the prosthetic valve of FIGS. 2A-2B and shownin the second configuration and a third configuration, respectively.

FIGS. 3A-3C are schematic illustrations of an outer frame of aside-delivered transcatheter prosthetic heart valve, according to anembodiment, and shown in a delivery configuration, a seatingconfiguration, and a deployed configuration, respectively.

FIG. 4 is a perspective view of a prosthetic valve according to anembodiment.

FIG. 5 is a top perspective view a supra-annular region of an outersupport frame of the prosthetic valve shown in FIG. 4.

FIG. 6 is a distal perspective view a transannular region of the outersupport frame of the prosthetic valve shown in FIG. 4.

FIG. 7 is a distal perspective view a subannular region of the outersupport frame of the prosthetic valve shown in FIG. 4.

FIG. 8 is a top perspective view an inner frame of a flow controlcomponent included in the prosthetic valve shown in FIG. 4.

FIG. 9 is a side perspective view of a leaflet band of the inner flowcontrol component having leaflet pockets sewn into a structural band andshown in a cylindrical configuration suitable for coupling to the innerframe of FIG. 8.

FIG. 10 is a bottom view of the leaflet band of FIG. 9 in thecylindrical configuration and showing partial coaptation of the leafletsto form a partially closed fluid-seal.

FIGS. 11-14 are bottom perspective views is a bottom-side perspectiveview of a side-delivered transcatheter prosthetic heart valve, accordingto an embodiment, and showing a sequence of actuating one or moreportions of the prosthetic valve to reduce a perimeter and/orcircumference of a subannular member to facilitate deployment of thevalve in the native annulus.

FIGS. 15 and 16 are a top view and a bottom perspective view,respectively, of a prosthetic valve removably coupled to at least aportion of a delivery and/or actuating system, according to anembodiment.

FIGS. 17-20 are bottom perspective views of a prosthetic valve andillustrating a process of transitioning a proximal anchoring element ofthe prosthetic valve between a first configuration and a secondconfiguration, according to an embodiment.

FIGS. 21 and 22 are a side perspective view and a bottom view,respectively, of a prosthetic valve and illustrating a supra-annularmember having a bowed configuration, according to an embodiment.

FIGS. 23A-23C are schematic illustrations of a side-deliverableprosthetic valve and at least a portion of a delivery system fordelivering the prosthetic valve, according to an embodiment.

FIG. 24 is a partially exploded perspective view of a delivery systemfor side-delivery of a prosthetic valve according to an embodiment.

FIGS. 25A-25E are various views of a compression device included in thedelivery system of FIG. 24.

FIG. 26A is a side view of the compression device of FIGS. 25A-25E andshown without a coupling member.

FIG. 26B is a cross-sectional view of the compression device taken alongthe line 26B-26B in FIG. 26A, and FIG. 26C is a side perspective view ofa semi-compressed prosthetic valve corresponding to a size of a lumen ofthe compression device at the cross-sectional plane shown in FIG. 26B.

FIG. 26D is a cross-sectional view of the compression device taken alongthe line 26D-26D in FIG. 26A, and FIG. 26E is a side perspective view ofa semi-compressed prosthetic valve corresponding to a size of a lumen ofthe compression device at the cross-sectional plane shown in FIG. 26D.

FIG. 26F is a cross-sectional view of the compression device taken alongthe line 26F-26F in FIG. 26A, and FIG. 26G is a side perspective view ofa semi-compressed prosthetic valve corresponding to a size of a lumen ofthe compression device at the cross-sectional plane shown in FIG. 26F.

FIG. 27 is a perspective view of a loading device included in thedelivery system of FIG. 24.

FIG. 28 is a perspective view of a delivery device included in thedelivery system of FIG. 24.

FIG. 29 is a perspective view of a control device included in thedelivery system of FIG. 24.

FIG. 30 is a cross-sectional view of a multi-lumen control catheterincluded in the control device of FIG. 29 and taken along the line30-30.

FIG. 31A is perspective views of a distal end portion of the controldevice of FIG. 29 illustrating a yoke included in the distal endportion.

FIGS. 31B and 31C are perspective views of the distal end portion of thecontrol delivery of FIG. 29 at least partially disposed in a deliverycatheter of the delivery system and shown in a first configuration and asecond configuration, respectively.

FIG. 32 is a perspective view of the distal end portion of the controldevice of FIG. 29 illustrating the yoke removably coupled to a pair oftethers.

FIG. 33 is a side perspective view of the distal end portion of thecontrol device of FIG. 29 illustrating the yoke and the pair of tethersremovably coupling the yoke to a prosthetic valve.

FIGS. 34A and 34B are side perspective views of the distal end portionof the control device of FIG. 29 illustrating the yoke, the pair oftethers, a tension member, and a guidewire catheter extending from themulti-lumen control catheter, with the multi-lumen control catheterbeing shown in a first configuration and a second configuration,respectively.

FIGS. 35-38 are cross-sectional views of portions of the delivery systemof FIG. 24 illustrating a process of compressing a prosthetic valve andloading the prosthetic valve into the delivery device for side-deliveryto a target location in a patient.

FIG. 39 is an enlarged cross-section view of a portion the deliverysystem identified by the region A in FIG. 38 and showing theside-deliverable valve being loaded into the delivery device.

FIGS. 40-42 are various views of a prosthetic valve illustrating way ofattaching at least one of a guidewire and/or a control catheter to oneor more portions of the prosthetic valves, each according to a differentembodiment.

FIG. 43 is a partially exploded perspective view of at least a portionof a delivery system for side-delivery of a prosthetic valve accordingto an embodiment.

FIGS. 44 and 45 are side perspective views of a loading device includedin the delivery system of FIG. 43 and illustrating a compression processassociated with inserting the prosthetic valve into the loading device.

FIG. 46 is a side perspective view of the loading device, with thecompressed prosthetic valve disposed therein, connected to a deliverydevice of the delivery system of FIG. 43.

FIGS. 47A-47E are cross-sectional views of a portion of a deliverysystem illustrating a process of using a compression device of thedelivery system to compress a prosthetic valve for insertion into aloading device of the delivery system, according to an embodiment.

FIGS. 47F and 47G are cross-sectional views of a portion of the deliverysystem of FIG. 47A illustrating a process of using a pushing device ofthe delivery system to push the compressed prosthetic valve from theloading device into a lumen of a delivery catheter.

FIGS. 48A-48D are cross-sectional views of a portion of a deliverysystem illustrating a process of using a compression device of thedelivery system to compress a prosthetic valve, having a guidewiredevice and a control device attached to a proximal portion thereof, forinsertion into a loading device of the delivery system, according to anembodiment.

FIG. 48E is a side view of the portion of the delivery system of FIG.48A illustrating the compression device being laterally separated fromaround the guidewire device and the control device to allow thecompression device to be removed from the loading device.

FIG. 48F is a side view of a portion of the delivery system of FIG. 48Aillustrating a portion of the loading device, with the compressedprosthetic valve disposed therein, disposed in a lumen of a deliverycatheter included in the delivery system.

FIG. 48G is a side view of a portion of the delivery system of FIG. 48Aillustrating a process of using a pushing device of the delivery systemto push the compressed process from the loading device into the lumen ofa delivery catheter.

FIGS. 49A-49C are a side perspective view, and partial cross-sectionalviews, respectively, of a compression device of a delivery system and aprosthetic valve and illustrating a process of using a pulling devicecoupled to a proximal side of the prosthetic valve to pull theprosthetic valve through the compression device and into a loadingdevice, according to an embodiment.

FIGS. 50A-50E are proximal views of a prosthetic valve showing a processof compressing the prosthetic valve in an axial direction and a lateraldirection from an expanded or deployment configuration to a compressedor delivery configuration, according to an embodiment.

FIG. 50F is a cross-sectional view of a delivery catheter illustratingthe prosthetic valve in the compressed or delivery configurationdisposed in a lumen thereof.

FIGS. 51A and 51B are side view illustrations of a prosthetic valve in acompressed or delivery configuration disposed in a loading (or control)catheter device, which can be used to advance the prosthetic valve inthe compressed or delivery configuration through a delivery catheter andinto a target location within a patient (e.g., a space within a humanheart), accord to an embodiment.

FIGS. 52A-52C are side perspective view illustrations of a portion of aproximal anchoring element of a prosthetic valve being coupled to anddecoupled from an actuator or the like, according to an embodiment.

FIGS. 53A-53C are side view schematic illustrations of a prostheticvalve showing a sequence of retracting the valve into a portion of adelivery and/or retraction system according to an embodiment.

FIGS. 54A to 541 are top perspective views of a valve sequenceillustrations showing a sequence of retracting a prosthetic valve into aportion of a delivery and/or retraction system according to anembodiment.

FIGS. 55A-55D are schematic illustrations of an anterior side view of adelivery catheter having an extendable capture element for capturingand/or encompassing at least a portion of a prosthetic valve tofacilitate a compression and retrieval process thereof, according to anembodiment.

FIGS. 56A and 56B are schematic illustrations of an anterior side viewof a delivery catheter and showing a pushing/pulling member extendingfrom the delivery system and attaching to a proximal side of aprosthetic valve and a compression tether for at least partiallycompressing the proximal side of the prosthetic valve to allow for atleast partial retrieval of the prosthetic valve into the deliverycatheter, according to an embodiment.

FIGS. 57A and 57B are schematic illustrations of an anterior side viewof a delivery catheter and showing a pushing/pulling member extendingfrom the delivery system and attaching to a proximal side of aprosthetic valve and (i) a compression tether and (ii) an extendablecapture element for at least partially compressing the proximal side ofthe prosthetic valve to allow for at least partial retrieval of theprosthetic valve into the delivery catheter, according to an embodiment.

FIGS. 58A and 58B are proximal end schematic illustrations of aprosthetic valve, illustrating a compression tether routed through oneor more portions of a proximal side of the prosthetic valve used to atleast partially compress the proximal side of the prosthetic valve tofacilitate a retrieval process, according to an embodiment.

FIGS. 59A-59C are schematic illustration of an anterior side view of adelivery catheter and showing a process of retrieving a prosthetic valveinto the delivery catheter using a pushing/pulling member, at least onecompression tether, and an extendable capture element, according to anembodiment.

FIG. 60A is an exploded side view illustration of at least a portion ofa delivery and/or retrieval system including, for example, a captureelement, a prosthetic valve, and a delivery catheter, according to anembodiment.

FIG. 60B is a side view of the portion of the delivery and/or retrievalsystem of FIG. 60A showing each of the prosthetic valve in a compressedconfiguration and the capture element disposed in a lumen of thedelivery catheter.

FIG. 60C is a side view of the portion of the delivery and/or retrievalsystem of FIG. 60A showing the prosthetic valve distal to the deliverycatheter and the capture element deployed from the delivery catheter andat least partially encompassing the prosthetic valve.

FIGS. 61A-61G are various views of at least a portion of a deliveryand/or retrieval system and showing a capture element being used tofacilitate compression of a prosthetic valve to allow the prostheticvalve to be retrieved into a lumen of a delivery catheter, according toan embodiment.

FIGS. 62A-62B are top views of at least a portion of a delivery and/orretrieval system and showing a process of extending a capture elementaround a proximal side of a prosthetic valve and a portion of a controldevice having a control catheter and a yoke coupled to the proximal sideof the prosthetic valve, according to an embodiment.

FIG. 63A is a perspective view of a portion of a capture element sheathwith an expansion feature included in a delivery and retrieval system,according to an embodiment.

FIGS. 63B-63D are side perspective views of a prosthetic valve and aportion of the delivery and retrieval system showing a process ofextending a delivery catheter, over the expansion feature of the captureelement sheath, and about a portion of the prosthetic valve.

FIG. 63E is a side perspective view of the prosthetic valve and portionof the delivery and retrieval system of FIGS. 63B-63D showing thecapture element facilitating a process of compressing and/or retrievingat least a portion of the prosthetic valve into the delivery catheter.

FIGS. 64A and 64B are each a top view of a laser-cut workpiececonfigured to be formed into at least a part of a distal end of acontrol device having, for example, a yoke, according to differentembodiments.

FIG. 65 is a flowchart illustrating a method of compressing a prostheticvalve into a delivery configuration for side-delivery to a patient via adelivery catheter, according to an embodiment.

FIG. 66 is a flowchart illustrating a method of preparing a prostheticvalve for side-delivery to a patient via a delivery catheter, accordingto an embodiment.

FIG. 67 is a flowchart illustrating a method of preparing a prostheticvalve for side-delivery to a patient through a lumen of a deliverycatheter included in a delivery device, according to an embodiment.

FIG. 68 is a flowchart illustrating a method of using a control deviceto selectively control a side-deliverable transcatheter prosthetic valveduring at least one of delivery and deployment, according to anembodiment.

DETAILED DESCRIPTION

Disclosed embodiments are directed to side-deliverable transcatheterprosthetic valves (and/or components thereof) and methods of loading,delivering, deploying, and/or retrieving the prosthetic valves (and/orcomponents thereof). In some embodiments, a side-deliverable prostheticheart valve can include an outer frame and a flow control component. Theouter frame can have a supra-annular region, a subannular region, and atransannular region coupled therebetween. The subannular region can forma distal anchoring element and a proximal anchoring element. The flowcontrol component can be mounted to the supra-annular region of theouter frame such that at least a portion of the flow control componentis disposed in the transannular region. The prosthetic valve can beplaced in a delivery configuration for side-delivery of the prostheticvalve to a heart of a patient via a delivery catheter of a deliverysystem. The prosthetic valve can be allowed to transition to an expandedor released configuration when released from the delivery catheter. Insome implementations, the subannular region of the outer frame can be ina first configuration as the prosthetic valve is seated in an annulus ofa native heart valve and can be transitioned to a second configurationafter the prosthetic valve is seated in the annulus of the native heartvalve.

In some embodiments, a delivery and/or retrieval system can facilitatethe compression, loading, advancing, delivering, and/or deploying of aprosthetic valve through a delivery catheter of the delivery system andto a desired position relative to a native valve annulus. In someimplementations, the delivery and/or retrieval system can include aself-expanding capture element that can extend from an end of a deliverycatheter and/or other member of the delivery system to funnel, wrap,and/or at least partially capture the prosthetic valve during or afterdeployment to facilitate a compression of the valve and an at leastpartial retrieval thereof.

In some embodiments, a delivery system for side-delivery of atranscatheter prosthetic valve can include a compression device, aloading device, and a delivery device. The compression device defines alumen extending through a proximal end and a distal end. The perimeterof the lumen at the proximal end being larger than a perimeter of thelumen at the distal end. The loading device defines a lumen extendingthrough a proximal end and a distal end of the loading device. Aperimeter of the lumen of the loading device is substantially similar tothe perimeter of the lumen at the distal end of the compression device.The proximal end of the loading device is removably coupleable to thecompression device. The distal end of the loading device includes afirst gate that is movable between an open state and a closed state inwhich the first gate at least partially occludes the lumen of theloading device. The delivery device has a handle and a delivery catheterextending distally from the handle. The handle and the delivery cathetercollectively define a lumen extending through the delivery device. Aperimeter of the lumen of the delivery device is substantially similarto the perimeter of the lumen of the loading device. A proximal end ofthe handle is coupleable to the distal end of the loading device andincludes a second gate movable between an open state and a closed statein which the second gate at least partially occludes the lumen of thedelivery device.

In some implementations, a method for compressing a prosthetic valveinto a delivery configuration for side-delivery to a patient by adelivery catheter can include compressing the prosthetic valve along alateral axis of the prosthetic valve perpendicular to a central axis ofthe prosthetic valve, which in turn, is parallel to a fluid flowdirection through the prosthetic valve. After compressing, theprosthetic valve is inserted into a proximal end of a compressiondevice. The compression device defines a lumen extending through theproximal end and a distal end. A perimeter of the lumen at the proximalend is larger than a perimeter of the lumen at the distal end. Theprosthetic valve is advanced through the lumen of the compression deviceto compress the prosthetic valve along the central axis. The prostheticvalve in the delivery configuration is transferred from the distal endof the compression device into a loading device coupled to the distalend of the compression device. The loading device defines a lumen havinga perimeter that is substantially similar to (i) the perimeter of thelumen at the distal end of the compression device and (ii) a perimeterof a lumen of the delivery catheter.

In some implementations, a method for preparing a side-deliverableprosthetic valve for side-delivery to a patient via a delivery cathetercan include compressing the prosthetic valve along a lateral axis of theprosthetic valve perpendicular to a central axis of the prostheticvalve, which in turn, is parallel to a fluid flow direction through theprosthetic valve. After compressing, the prosthetic valve is insertedinto a lumen of a compression device. The prosthetic valve is pulledthrough the lumen of the compression device and into a lumen of aloading device coupled to the compression device via a tether attachedto a distal end portion of the prosthetic valve. The prosthetic valve iscompressed along the central axis such that the prosthetic valve is in adelivery configuration when in the lumen of the loading device. Thetether is removed from the distal end portion of the prosthetic valveand a distal end and a distal end of the loading device is coupled to adelivery device including the delivery catheter.

In some implementations, A method for preparing a side-deliverableprosthetic valve for side-delivery to a patient through a lumen of adelivery catheter included in a delivery device can include compressingthe prosthetic valve along a central axis parallel to a fluid flowdirection through the prosthetic valve and a lateral axis perpendicularto the central axis to transition the prosthetic valve from an expandedconfiguration to a delivery configuration. The prosthetic valve in thedelivery configuration is advanced into a lumen of a loading devicewhile a first gate at a distal end of the loading device is in a closedstate to at least partially occlude the lumen of the loading device. Adistal end of the loading device is coupled to a handle of the deliverydevice while (i) the first gate is in the closed state and (ii) while asecond gate at a proximal end of the handle is in a closed state to atleast partially occlude a lumen of the handle. The lumen of the deliverycatheter is in fluid communication with the lumen of the handle distalto the second gate. After coupling, each of the first gate and thesecond gate is transitioned from the closed state to an open state.

In some embodiments, an apparatus for selectively engaging aside-deliverable transcatheter prosthetic valve can include amulti-lumen catheter having a distal end and a proximal end. A controlportion is coupled to the proximal end of the multi-lumen catheter and ayoke coupled to the distal end of the multi-lumen catheter. A firsttether is extendable through a first control arm of the control portionand a first lumen of the multi-lumen catheter, and a portion of thefirst tether is configured to be looped through a first side of theyoke. A second tether is extendable through a second control arm of thecontrol portion and a second lumen of the multi-lumen catheter, and aportion of the second tether is configured to be looped through a secondside of the yoke. A tension member is extendable through a third controlarm of the control portion and a third lumen of the multi-lumencatheter, and a portion of the tension member is configured to beremovably coupled to a proximal subannular anchoring element of theprosthetic valve.

In some embodiments, a control device can include at least a controlcatheter having a first tether, a second tether, and a tension memberextending therethrough, and a yoke coupled to a distal end of thecontrol catheter. In some implementations, a method of using the controldevice to selectively control a side-deliverable transcatheterprosthetic valve during at least one of delivery and deployment caninclude increasing a tension along the first tether and the secondtether to secure the yoke against a surface of the prosthetic valve. Theprosthetic valve is advanced through a lumen of a delivery catheterwhile the yoke is secured against the surface of the prosthetic valve.The prosthetic valve is released from a distal end of the deliverycatheter. After releasing, a tension along the tension member isincreased to transition a proximal subannular anchoring element from afirst configuration to a second configuration. The prosthetic valve isseated in an annulus of a native valve in response to a force exerted bythe yoke on the surface of the prosthetic valve. After seating theprosthetic valve, the tension along the tension member is released toallow the proximal subannular anchoring element to transition from thesecond configuration toward the first configuration. The control deviceis then decoupled from the prosthetic valve.

In some embodiments, a delivery and retrieval system for aside-deliverable prosthetic valve can include a catheter, a captureelement, and a control device. The catheter has a distal end and definesa lumen. The prosthetic valve has a delivery configuration for sidedelivery through the lumen of the catheter and a deploymentconfiguration when released from the distal end of the catheter. Thecapture element is disposable in the lumen of the catheter in asubstantially closed configuration and can be transitioned to an openconfiguration when advanced beyond the distal end of the catheter. Thecontrol device can be at least partially disposed in the lumen of thecatheter and can be attached to the prosthetic valve. The control deviceis operable to (i) exert a distally directed force to advance theprosthetic valve in the delivery configuration through the lumen of thecatheter and (ii) exert a proximally directed force to pull theprosthetic valve in the deployment configuration into the distal end ofthe catheter. The capture element can be extended around at least aportion of the prosthetic valve to transition the prosthetic valve fromthe deployment configuration to the delivery configuration as thecontrol device pulls the prosthetic valve into the distal end of thecatheter.

In some embodiments, a retrieval system for a side-deliverableprosthetic valve can include a control device and a self-expandingcapture element. The control device is removably coupleable to theprosthetic valve during delivery and deployment of the prosthetic valvein an annulus of a native heart valve. The self-expanding captureelement is extendable from a distal end of a delivery catheter to funnelor wrap at least a portion of the prosthetic valve at least partiallydeployed in the annulus to facilitate a compression of the prostheticvalve in response to a force exerted by the control device moving theprosthetic valve in a proximal direction toward the delivery catheter.

In some implementations, a method of retrieving a side-deliverableprosthetic heart valve can include extending a self-expanding captureelement from a distal end of a catheter disposed in a native atrium of aheart. The capture element is configured to have and/or define a cavityshape when in an extended position. The prosthetic heart valve is pulledinto the cavity of the extended capture element to facilitate acompressing of the prosthetic heart valve. The pulling of the prostheticheart valve into the capture element is operable to transition thecapture element from the extended position to or toward a retractedposition, in which the prosthetic heart valve is wrapped by the captureelement. After wrapping, the prosthetic heart valve that is wrapped (atleast partially) by the capture element is pulled into the catheterusing a cable.

Any of the prosthetic heart valves described herein can be a relativelylow profile, side-deliverable implantable prosthetic heart valve (alsoreferred to herein as “prosthetic valve” or simply, “valve”). Any of theprosthetic valves can be transcatheter prosthetic valves configured tobe delivered into a heart via a delivery catheter. The prosthetic valvescan have at least an annular outer valve frame and an inner flow controlcomponent (e.g., a 2-leaflet or 3-leaflet valve, sleeve, and/or thelike) mounted within and/or extending through a central lumen oraperture of the valve frame. The flow control component can beconfigured to permit blood flow in a first direction through an inflowend of the valve and block blood flow in a second direction, oppositethe first direction, through an outflow end of the valve. In addition,the prosthetic valves can include a single anchoring element or multipleanchoring elements configured to anchor the valve in the annulus of anative valve.

Any of the prosthetic valves described herein can be configured totransition between a compressed or delivery configuration forintroduction into the body using the delivery catheter, and an expandedor deployed configuration for implanting at a desired location in thebody. For example, any of the embodiments described herein can be aballoon-inflated prosthetic valve, a self-expanding prosthetic valve,and/or the like.

Any of the prosthetic valves described herein can be compressible—intothe compressed or delivery configuration—in a lengthwise or orthogonaldirection relative to the central axis of the flow control component(e.g., along a longitudinal axis) that can allow a large diameter valve(e.g., having a height of about 5-60 mm and a diameter of about 20-80mm) to be delivered and deployed from the inferior vena cava directlyinto the annulus of a native mitral or tricuspid valve using, forexample, a 24-36 Fr delivery catheter. The longitudinal axis can besubstantially parallel to a lengthwise cylindrical axis of the deliverycatheter, which can allow deployment of the prosthetic valves without anacute angle of approach common in traditional transcatheter delivery.

Any of the prosthetic valves described herein can have a central axisthat is co-axial or at least substantially parallel with blood flowdirection through the valve. In some embodiments, the compressed ordelivery configuration of the valve is orthogonal to the blood flowdirection. In some embodiments, the compressed or delivery configurationof the valve is parallel to or aligned with the blood flow direction. Insome embodiment, the valve can be compressed to the compressed ordelivery configuration in two directions—orthogonal to the blood flowdirection (e.g., laterally) and parallel to the blood flow (e.g.,axially). In some embodiments, a long-axis or longitudinal axis isoriented at an intersecting angle of between 45-135 degrees to the firstdirection when in the compressed or delivery configuration and/or theexpanded or deployed configuration.

Any of the prosthetic valves described herein can include an outersupport frame that includes a set of compressible wire cells having anorientation and cell geometry substantially orthogonal to the centralaxis to minimize wire cell strain when the outer support frame is in adelivery configuration (e.g., a compressed configuration, a rolled andcompressed configuration, or a folded and compressed configuration).

Any of the outer support frames described herein can have asupra-annular region, a subannular region, and a transannular regioncoupled therebetween. The supra-annular region can form, for example, anupper collar portion of the outer support frame and can include anynumber of features configured to engage native tissue, an inner flowcontrol component of the prosthetic valve, and/or a delivery, actuator,and/or retrieval mechanism. The subannular region can form, for example,a distal anchoring element and a proximal anchoring element configuredto engage subannular (ventricle) tissue when the prosthetic valve isseated in the native annulus. The transannular region can be coupledbetween the supra-annular region and the subannular region. Thetransannular region can form a shape such as a funnel, cylinder, flatcone, or circular hyperboloid when the outer support frame is in anexpanded configuration. In some embodiments, the outer support frame isformed from a wire, a braided wire, or a laser-cut wire frame, and iscovered with a biocompatible material. The biocompatible material cancover the outer support frame such that an inner surface is covered withpericardial tissue, an outer surface is covered with a woven syntheticpolyester material, and/or both the inner surface is covered withpericardial tissue and the outer surface is covered with a wovensynthetic polyester material.

Any of the outer support frames described herein can have a side profileof a flat cone shape having an outer diameter R of 40-80 mm, an innerdiameter r of 20-60 mm, and a height of 5-60 mm. In some embodiments, anannular support frame has a side profile of an hourglass shape having atop diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, aninternal diameter r of 20-60 mm, and a height of 5-60 mm.

Any of the prosthetic valves described herein can include one or moreanchoring element extending from, coupled to, and/or otherwise integralwith a portion of a valve frame. For example, any of the prostheticvalves can include a distal anchoring element, which can be used, forexample, as a Right Ventricular Outflow Tract (“RVOT”) tab or a LeftVentricular Outflow Tract (“LVOT”) tab. Any of the valves describedherein can also include an anchoring element extending from a proximalsided of the valve frame, which can be used, for example, to anchor thevalve to proximal subannular tissue of the ventricle. The anchoringelements can include and/or can be formed from a wire loop or wireframe, an integrated frame section, and/or a stent, extending from about10-40 mm away from the tubular frame. For example, any of the prostheticvalves described herein can include a valve frame having a wire or lasercut subannular region or member that forms a distal and proximalanchoring element.

Any of the prosthetic valves described herein can also include (i) adistal upper (supra-annular) anchoring element extending from, attachedto, and/or otherwise integral with a distal upper edge of the valveframe and (ii) a proximal upper (supra-annular) anchoring elementextending from, attached to, and/or otherwise integral with a proximalupper edge of the valve frame. The distal and proximal upper anchoringelements can include or be formed from a wire loop or wire frameextending from about 2-20 mm away from the valve frame. In someembodiments, the prosthetic valves described herein can include a wireor laser cut supra-annular region or member that forms the distal andproximal upper anchoring elements. The distal and proximal upperanchoring elements are configured to be positioned into a supra-annularposition in contact with and/or adjacent to supra-annular tissue of theatrium. In some implementations, the prosthetic valves described hereincan be cinched or at least partially compressed after being seated in anative annulus such that the proximal and distal upper anchoringelements exert a force on supra-annular tissue and the proximal anddistal lower anchoring elements exert a force in an opposite directionon subannular tissue, thereby securing the prosthetic valve in thenative annulus. Any of the valves described herein can also include ananterior or posterior anchoring element extending from and/or attachedto an anterior or posterior side of the valve frame, respectively.

Any of the prosthetic valves described herein can include an inner flowcontrol component that has a leaflet frame with 2-4 flexible leafletsmounted thereon. The 2-4 leaflets are configured to permit blood flow ina first direction through an inflow end of the flow control componentand block blood flow in a second direction, opposite the firstdirection, through an outflow end of the flow control component. Theleaflet frame can include two or more panels of diamond-shaped oreye-shaped wire cells made from heat-set shape memory alloy materialsuch as, for example, Nitinol. The leaflet frame can be configured to befoldable along a z-axis (e.g., a longitudinal axis) from a rounded orcylindrical configuration to a flattened cylinder configuration, andcompressible along a vertical y-axis (e.g., a central axis) to acompressed configuration. In some implementations, the leaflet frame caninclude a pair of hinge areas, fold areas, connection points, etc. thatcan allow the leaflet frame to be folded flat along the z-axis prior tothe leaflet frame being compressed along the vertical y-axis. Theleaflet frame can be, for example, a single-piece structure with two ormore living hinges (e.g., stress concentration riser and/or any suitablestructure configured to allow for elastic/nonpermanent deformation ofthe leaflet frame) or a two-piece structure where the hinge areas areformed using a secondary attachment method (e.g. sutures, fabrics,molded polymer components, etc.)

In some embodiments, the inner flow control component in an expandedconfiguration forms a shape such as a funnel, cylinder, flat cone, orcircular hyperboloid. In some embodiments, the inner flow controlcomponent has a leaflet frame with a side profile of a flat cone shapehaving an outer diameter R of 20-60 mm, an inner diameter r of 10-50 mm,where diameter R is great than diameter r, and a height of 5-60 mm. Insome embodiments, the leaflet frame is comprised of a wire, a braidedwire, or a laser-cut wire frame. In some embodiments, the leaflet framecan have one or more longitudinal supports integrated into or mountedthereon and selected from rigid or semi-rigid posts, rigid or semi-rigidribs, rigid or semi-rigid batons, rigid or semi-rigid panels, andcombinations thereof.

Any of the prosthetic valves and/or components thereof may be fabricatedfrom any suitable biocompatible material or combination of materials.For example, an outer valve frame, an inner valve frame (e.g., of aninner flow control component), and/or components thereof may befabricated from biocompatible metals, metal alloys, polymer coatedmetals, and/or the like. Suitable biocompatible metals and/or metalalloys can include stainless steel (e.g., 316 L stainless steel), cobaltchromium (Co—Cr) alloys, nickel-titanium alloys (e.g., Nitinol®), and/orthe like. Moreover, any of the outer or inner frames described hereincan be formed from superelastic or shape-memory alloys such asnickel-titanium alloys (e.g., Nitinol®). Suitable polymer coatings caninclude polyethylene vinyl acetate (PEVA), poly-butyl methacrylate(PBMA), translute Styrene Isoprene Butadiene (SIBS) copolymer,polylactic acid, polyester, polylactide, D-lactic polylactic acid(DLPLA), polylactic-co-glycolic acid (PLGA), and/or the like. Some suchpolymer coatings may form a suitable carrier matrix for drugs such as,for example, Sirolimus, Zotarolimus, Biolimus, Novolimus, Tacrolimus,Paclitaxel, Probucol, and/or the like.

Some biocompatible synthetic material(s) can include, for example,polyesters, polyurethanes, polytetrafluoroethylene (PTFE) (e.g.,Teflon), and/or the like. Where a thin, durable synthetic material iscontemplated (e.g., for a covering), synthetic polymer materials suchexpanded PTFE or polyester may optionally be used. Other suitablematerials may optionally include elastomers, thermoplastics,polyurethanes, thermoplastic polycarbonate urethane, polyether urethane,segmented polyether urethane, silicone polyether urethane,polyetheretherketone (PEEK), silicone-polycarbonate urethane,polypropylene, polyethylene, low-density polyethylene (LDPE),high-density polyethylene (HDPE), ultra-high density polyethylene(UHDPE), polyolefins, polyethylene-glycols, polyethersulphones,polysulphones, polyvinylpyrrolidones, polyvinylchlorides, otherfluoropolymers, polyesters, polyethylene-terephthalate (PET) (e.g.,Dacron), Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), poly(D,L-lactide/glycolide) copolymer (PDLA), silicone polyesters, polyamides(Nylon), PTFE, elongated PTFE, expanded PTFE, siloxane polymers and/oroligomers, and/or polylactones, and block co-polymers using the same.

Any of the outer valve frames, inner valve frames (e.g., of the flowcontrol components), and/or portions or components thereof can beinternally or externally covered, partially or completely, with abiocompatible material such as pericardium. A valve frame may also beoptionally externally covered, partially or completely, with a secondbiocompatible material such as polyester or Dacron®. Disclosedembodiments may use tissue, such as a biological tissue that is achemically stabilized pericardial tissue of an animal, such as a cow(bovine pericardium), sheep (ovine pericardium), pig (porcinepericardium), or horse (equine pericardium). Preferably, the tissue isbovine pericardial tissue. Examples of suitable tissue include that usedin the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all productscurrently used in surgical procedures, and which are marketed as beingharvested generally from cattle less than 30 months old.

Any method for manufacturing prosthetic valves described herein caninclude using additive or subtractive metal or metal-alloy manufacturingto produce, for example, a compressible/expandable outer support frameand/or a compressible/expandable inner leaflet frame. Additive metal ormetal-alloy manufacturing can include but is not limited to 3D printing,direct metal laser sintering (powder melt), and/or the like. Subtractivemetal or metal-alloy manufacturing can include but is not limited tophotolithography, laser sintering/cutting, CNC machining, electricaldischarge machining, and/or the like. Moreover, any of the manufacturingprocesses described herein can include forming and/or setting (e.g.,heat setting) a cut or machined workpiece into any suitable shape, size,and/or configuration. For example, any of the outer support framesand/or inner leaflet frames described herein can be laser cut from oneor more workpieces and heat set into a desired shape, size, and/orconfiguration. Moreover, any of the frames described herein can includemultiple independent components that are formed into desired shapes andcoupled together to form the frames.

In some embodiments, a process of manufacturing can further includemounting 2-4 flexible leaflets to the inner leaflet frame tocollectively form a flow control component, mounting the flow controlcomponent within the outer support frame, and/or covering at least aportion of the outer support frame with a pericardium material orsimilar biocompatible material.

Any of the delivery systems described herein can be configured todeliver a side-deliverable transcatheter prosthetic valve to a targetlocation within a patient (e.g., to or into an annulus of a native heartvalve). Such delivery systems can include one or more of the followingcomponents: (i) a dilator for dilating at least a portion of an arterialpathway to the heart such as the femoral artery, the IVC, and/or theSVC, (ii) a compression device such as a funnel or the like forcompressing the prosthetic valve to a delivery configuration, (iii) aloader, capsule, chamber, etc., for receiving the prosthetic valve inthe delivery configuration, (iv) a delivery device including a handleand a delivery catheter extending therefrom for delivering theprosthetic valve in the delivery configuration to a space within theheart such as an atrium, (v) a control device, controller, and/oractuator such as a multi-lumen control catheter or the like for engagingand/or actuating one or more portions of the prosthetic valve, and (vi)a guidewire catheter for coupling to the prosthetic valve and forreceiving a guidewire allowing the prosthetic valve to be advanced alongthe guidewire during delivery and/or deployment.

Any of the delivery systems described herein can include a deliverycatheter for side-delivery of a side-deliverable prosthetic valve. Thedelivery catheter can include an outer shaft having an outer proximalend, an outer distal end, and an outer shaft lumen, wherein the outerdistal end is closed with an atraumatic ball mounted thereon. The outershaft lumen has an inner diameter of 8-10 mm sized for passage of a sidedelivered transcatheter prosthetic valve (e.g., a prosthetic tricuspidvalve and/or a prosthetic mitral valve) therethrough.

Any of the delivery systems described herein can include a deliverycatheter, a control catheter, and/or other suitable portion thatincludes one or more members, components, features, and/or the likeconfigured to facilitate at least partial retrieval of the valve from anannulus of a native heart valve. For example, such a delivery system caninclude, for example, a self-expanding capture element that can beplaced in an extended position to at least partially surround and/orcapture a portion of the prosthetic valve. In some implementations, theprosthetic valve can be pulled and/or drawn into the self-expandingcapture element by virtue of a control catheter and/or other componentattached to the prosthetic valve during delivery and/or deployment. Assuch, the self-expanding capture element can surround and/or capture atleast a portion of the prosthetic valve, which in turn, can facilitate atransitioning of the prosthetic valve from an at least partiallyexpanded configuration to an at least partially compressedconfiguration, allowing the prosthetic valve to be at least partiallyretracted into the delivery catheter used to deliver the prostheticvalve.

Any method for delivering and deploying a prosthetic valve in an annulusof a native heart valve can include removably coupling a prostheticvalve or an outer frame thereof to a portion of a delivery system. Theprosthetic valve is placed into a delivery configuration, loaded into adelivery device including a delivery catheter, and advanced through alumen of a delivery catheter. The prosthetic valve can then be releasedfrom a distal end of the delivery catheter, which is disposed in anatrium of the heart. In some implementations, after releasing theprosthetic valve, a proximal anchoring element of a subannular member ofthe prosthetic valve can be placed in a first configuration and theprosthetic valve is seated in the annulus of the native heart valvewhile the proximal anchoring element is in the first configuration. Theproximal anchoring element can then be transitioned from the firstconfiguration to a second configuration after seating the prostheticvalve in the annulus. In some implementations, the method for deliveringand/or deploying the prosthetic valve can optionally include retrievingat least a portion of the prosthetic valve from the annulus to allow fora repositioning and/or reseating of at least a portion of the prostheticvalve.

Any method for delivering and/or deploying prosthetic heart valvesdescribed herein can include orthogonal delivery of the prosthetic heartvalve to a native annulus of a human heart that includes at least one of(i) advancing a delivery catheter to the tricuspid valve or pulmonaryartery of the heart through the inferior vena cava (IVC) via the femoralvein, (ii) advancing to the tricuspid valve or pulmonary artery of theheart through the superior vena cava (SVC) via the jugular vein, or(iii) advancing to the mitral valve of the heart through a trans-atrialapproach (e.g., fossa ovalis or lower), via the IVC-femoral or the SVCjugular approach; and (iv) delivering and/or deploying the prostheticheart valve to the native annulus by releasing the valve from thedelivery catheter.

Any method for delivering prosthetic valves described herein can includeplacing the prosthetic valves in a delivery configuration. The deliveryconfiguration can include at least one of (i) compressing the valvealong a central vertical axis to reduce a vertical dimension of thevalve from top to bottom to place the valve in the deliveryconfiguration, (ii) flattening the valve into two parallel panels thatare substantially parallel to the long-axis to place the valve in thedelivery configuration, or (iii) flattening the valve into two parallelpanels that are substantially parallel to the long-axis and thencompressing the valve along a central vertical axis to reduce a verticaldimension of the valve from top to bottom to place the valve in thedelivery configuration.

Any method for delivering prosthetic valves described herein can includeorthogonal delivery of the prosthetic valve to a desired location in thebody that includes advancing a delivery catheter to the desired locationin the body and delivering the prosthetic valve to the desired locationin the body by releasing the valve from the delivery catheter. The valveis in a compressed or delivery configuration when in the deliverycatheter and transitions to an expanded or released configuration whenreleased from the delivery catheter.

Any method for delivering prosthetic valves described herein can includereleasing the valve from the delivery catheter by (i) pulling the valveout of the delivery catheter using a pulling member (e.g., a wire orrod) that is releasably connected to a sidewall, a drum or collar,and/or an anchoring element (e.g., a distal anchoring element), whereinadvancing the pulling member away from the delivery catheter pulls thevalve out of the delivery catheter, or (ii) pushing the valve out of thedelivery catheter using a pushing member (e.g., a wire, rod, catheter,delivery member, yoke, etc.) that is releasably connected to a sidewall,a drum or collar, and/or an anchoring element (e.g., a proximal and/ordistal anchoring element), wherein advancing the pushing member out of adistal end of the delivery catheter pushes the valve out of the deliverycatheter. Moreover, releasing the valve from the delivery catheterallows the valve to transition and/or expand from its deliveryconfiguration to an expanded and/or deployment configuration.

Any method for delivering and/or deploying prosthetic valves describedherein can include releasing the valve from a delivery catheter whileincreasing blood flow during deployment of the valve by (i) partiallyreleasing the valve from the delivery catheter to establish blood flowaround the partially released valve and blood flow through the flowcontrol component; (ii) completely releasing the valve from the deliverycatheter while maintaining attachment to the valve to transition to astate with increased blood flow through the flow control component anddecreased blood flow around the valve; (iii) deploying the valve into afinal mounted or seated position in a native annulus to transition to astate with complete blood flow through the flow control component andminimal or no blood flow around the valve; and (iv) disconnecting andwithdrawing a positioning catheter, pulling or pushing wire or rod,delivery catheter, actuator, and/or other suitable portion of a deliverysystem.

In some implementations, prior to the disconnecting and withdrawing, themethod optionally can include transitioning the valve to a secured orcinched state via an actuator or portion of a delivery system such thatthe valve contacts annular tissue to secure the valve in the nativeannulus. In some implementations, prior to the disconnecting andwithdrawing, the method optionally can include retrieving, at least inpart, the valve from the annulus and repositioning at least a portion ofthe valve in the annulus. In some implementations, the retrieving caninclude retrieving and/or retracting at least a portion of the valveinto the delivery catheter.

Any method for delivering and/or deploying prosthetic valves describedherein can include positioning the valve or a portion thereof in adesired position relative to the native tissue. For example, the methodcan include positioning a distal anchoring tab of the heart valveprosthesis into a ventricular outflow tract of the left or rightventricle. In some embodiments, the method can further includepositioning an upper distal anchoring tab into a supra-annular position,where the upper distal anchoring tab provides a supra-annular downwardforce in the direction of the ventricle and the distal anchoring tab(e.g., the lower distal anchoring tab) provides a subannular upwardforce in the direction of the atrium. In some implementations, themethod can include partially inserting the prosthetic valve into theannulus such that a distal portion thereof contact native annular tissuewhile a proximal portion of the prosthetic valve is at least partiallycompressed and disposed in the delivery catheter. In some embodiments,the method can include rotating the heart valve prosthesis, using asteerable catheter, a yoke, a set of tethers, an actuator, and/or anyother portion of a delivery system (or combinations thereof), along anaxis parallel to the plane of the valve annulus. In some embodiments,the method can include transitioning one or more anchoring elements intoa desired position and/or state to engage native tissue surrounding atleast a portion of the annulus. In some implementations, one or moretissue anchors may be attached to the valve and to native tissue tosecure the valve in a desired position.

Any method for at least partially retrieving prosthetic valves describedherein can include (i) extending a self-expanding capture element from adistal end of a delivery catheter that is disposed in an atrium of aheart, wherein the capture element is configured to have a cavity shapewhen in an extended position, and (ii) pulling the heart valve into thecavity of the extended capture element to facilitate compression of theheart valve to or toward its delivery (compressed) configuration,wherein pulling the heart valve into the capture element transitions thecapture element from the extended position to a retracted position,wherein the heart valve is encompassed by the capture element in theretracted position, and wherein the heart valve-capture elementcombination is pulled into the delivery and/or retrieval catheter (e.g.,using a cable, control catheter, actuator, and/or any other suitableportion of a delivery and retrieval system. In some implementations, themethod optionally can include pre-compressing the valve by (a) suturinga proximal subannular anchoring element against an underside of anatrial or supra-annular collar or member, or (b) pinching proximalsidewall hips of the prosthetic valve, or (c) both, prior to pulling theheart valve into the cavity of the capture element, and subsequentlyinto the delivery and/or retrieval catheter.

Any of the prosthetic valves (or components, features, and/or aspectsthereof), delivery systems, methods of manufacturing, methods ofdelivery, methods of deployment, and/or methods of retrieval describedherein can be similar to and/or substantially the same as any of thosedescribed in International Patent Application No. PCT/US2019/051087,filed Sep. 19, 2019, entitled “Transcatheter Deliverable ProstheticHeart Valves and Method of Delivery” (referred to herein as “the '957PCT”); International Patent Application No. PCT/US2019/067010, filedDec. 18, 2019, entitled “Transcatheter Deliverable Prosthetic HeartValves and Methods of Delivery” (referred to herein as “the '010 PCT”);International Patent Application No. PCT/US2020/015231, filed Jan. 27,2020, entitled “Collapsible Inner Flow Control Component forSide-Deliverable Transcatheter Heart Valve Prosthesis” (referred toherein as “the '231 PCT”); International Patent Application No.PCT/US2020/031390, filed May 4, 2020, entitled “Cinch Device and Methodfor Deployment of a Side-Delivered Prosthetic Heart Valve in a NativeAnnulus,” (referred to herein as “the '390 PCT”); and/or InternationalPatent Application No. PCT/US2020/045108, filed Aug. 6, 2020, entitled“Side-Deliverable Transcatheter Prosthetic Valves and Methods forDelivering and Anchoring the Same” (referred to herein as “the '108PCT”), the disclosures of which are incorporated herein by reference intheir entireties.

Likewise, any of the prosthetic valves (or components, features, and/oraspects thereof), delivery systems, methods of manufacturing, methods ofdelivery, methods of deployment, and/or methods of retrieval describedherein can be similar to and/or substantially the same as any of thosedescribed in U.S. Provisional Patent Application No. 62/889,327(referred to herein as “the '327 “Provisional”); U.S. Provisional PatentApplication No. 62/891,964 (referred to herein as “the '964Provisional”); U.S. Provisional Patent Application No. 63/027,345(referred to herein as “the '345 Provisional”); and/or U.S. ProvisionalPatent Application No. 63/038,807 (referred to herein as “the '807Provisional”); to which this application claims priority to and thebenefit of and the disclosures of which have been incorporated above byreference in their entireties.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to limit the full scope of theclaims. Unless defined otherwise, all technical and scientific termsused herein have the same meanings as commonly understood by one ofordinary skill in the art. Nothing in this disclosure is to be construedas an admission that the embodiments described in this disclosure arenot entitled to antedate such disclosure by virtue of prior invention.

As used herein, the singular forms “a,” “an,” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. With respect to the use of substantially any plural and/orsingular terms herein, those having skill in the art can translate fromthe plural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

In general, terms used herein, and especially in the appended claims(e.g., bodies of the appended claims) are generally intended as “open”terms (e.g., the term “including” should be interpreted as “includingbut not limited to,” the term “having” should be interpreted as “havingat least,” etc.). Similarly, the terms “comprises” and/or “comprising,”when used in this specification, specify the presence of statedfeatures, integers (or fractions thereof), steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers (or fractions thereof), steps,operations, elements, components, and/or groups thereof. As used in thisdocument, the term “comprising” means “including, but not limited to.”

As used herein the term “and/or” includes any and all combinations ofone or more of the associated listed items. It should be understood thatany suitable disjunctive word and/or phrase presenting two or morealternative terms, whether in the description, claims, or drawings,contemplate the possibilities of including one of the terms, either ofthe terms, or both terms. For example, the phrase “A or B” will beunderstood to include the possibilities of “A” or “B” or “A and B.”

All ranges disclosed herein also encompass any and all possiblesubranges and combinations of subranges thereof unless expressly statedotherwise. Any listed range should be recognized as sufficientlydescribing and enabling the same range being broken down into at leastequal subparts unless expressly stated otherwise. As will be understoodby one skilled in the art, a range includes each individual member.

The term “valve prosthesis,” “prosthetic heart valve,” and/or“prosthetic valve” can refer to a combination of a frame and a leafletor flow control structure or component, and can encompass both completereplacement of an anatomical part (e.g., a new mechanical valve replacesa native valve), as well as medical devices that take the place ofand/or assist, repair, or improve existing anatomical parts (e.g., thenative valve is left in place).

Prosthetic valves disclosed herein can include a member (e.g., a frame)that can be seated within a native valve annulus and can be used as amounting element for a leaflet structure, a flow control component, or aflexible reciprocating sleeve or sleeve-valve. It may or may not includesuch a leaflet structure or flow control component, depending on theembodiment. Such members can be referred to herein as an “annularsupport frame,” “tubular frame,” “wire frame,” “valve frame,” “flange,”“collar,” and/or any other similar terms.

The term “flow control component” can refer in a non-limiting sense to aleaflet structure having 2-, 3-, 4-leaflets of flexible biocompatiblematerial such a treated or untreated pericardium that is sewn or joinedto an annular support frame, to function as a prosthetic heart valve.Such a valve can be a heart valve, such as a tricuspid, mitral, aortic,or pulmonary, that is open to blood flowing during diastole from atriumto ventricle, and that closes from systolic ventricular pressure appliedto the outer surface. Repeated opening and closing in sequence can bedescribed as “reciprocating.” The flow control component is contemplatedto include a wide variety of (bio)prosthetic artificial heart valves.Bioprosthetic pericardial valves can include bioprosthetic aorticvalves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, andbioprosthetic pulmonary valves.

Any of the disclosed valve embodiments may be delivered by atranscatheter approach. The term “transcatheter” is used to define theprocess of accessing, controlling, and/or delivering a medical device orinstrument within the lumen of a catheter that is deployed into a heartchamber (or other desired location in the body), as well as an item thathas been delivered or controlled by such as process. Transcatheteraccess is known to include cardiac access via the lumen of the femoralartery and/or vein, via the lumen of the brachial artery and/or vein,via lumen of the carotid artery, via the lumen of the jugular vein, viathe intercostal (rib) and/or sub-xiphoid space, and/or the like.Moreover, transcatheter cardiac access can be via the inferior vena cava(IVC), superior vena cava (SVC), and/or via a trans-atrial (e.g., fossaovalis or lower). Transcatheter can be synonymous with transluminal andis functionally related to the term “percutaneous” as it relates todelivery of heart valves. As used herein, the term “lumen” can refer tothe inside of a cylinder or tube. The term “bore” can refer to the innerdiameter of the lumen.

The mode of cardiac access can be based at least in part on a “bodychannel,” used to define a blood conduit or vessel within the body, andthe particular application of the disclosed embodiments of prostheticvalves can determine the body channel at issue. An aortic valvereplacement, for example, would be implanted in, or adjacent to, theaortic annulus. Likewise, a tricuspid or mitral valve replacement wouldbe implanted at the tricuspid or mitral annulus, respectively. Whilecertain features described herein may be particularly advantageous for agiven implantation site, unless the combination of features isstructurally impossible or excluded by claim language, any of the valveembodiments described herein could be implanted in any body channel.

The term “expandable” as used herein may refer to a prosthetic heartvalve or a component of the prosthetic heart valve capable of expandingfrom a first, delivery size or configuration to a second, implantationsize or configuration. An expandable structure, therefore, is notintended to refer to a structure that might undergo slight expansion,for example, from a rise in temperature or other such incidental cause,unless the context clearly indicates otherwise. Conversely,“non-expandable” should not be interpreted to mean completely rigid or adimensionally stable, as some slight expansion of conventional“non-expandable” heart valves, for example, may be observed.

The prosthetic valves disclosed herein and/or components thereof aregenerally capable of transitioning between two or more configurations,states, shapes, and/or arrangements. For example, prosthetic valvesdescribed herein can be “compressible” and/or “expandable” between anysuitable number of configurations. Various terms can be used to describeor refer to these configurations and are not intended to be limitingunless the context clearly states otherwise. For example, a prostheticvalve can be described as being placed in a “delivery configuration,”which may be any suitable configuration that allows or enables deliveryof the prosthetic valve. Examples of delivery configurations can includea compressed configuration, a folded configuration, a rolledconfiguration, and/or similar configuration or any suitable combinationsthereof. Similarly, a prosthetic valve can be described as being placedin an “expanded configuration,” which may be any suitable configurationthat is not expressly intended for delivery of the prosthetic valve.Examples of expanded configuration can include a released configuration,a relaxed configuration, a deployed configuration, a non-deliveryconfiguration, and/or similar configurations or any suitablecombinations thereof. Some prosthetic valves described herein and/orcomponents or features thereof can have a number of additionalconfigurations that can be associated with various modes, levels,states, and/or portions of actuation, deployment, engagement, etc.Examples of such configurations can include an actuated configuration, aseated configuration, a secured configuration, an engaged configuration,and/or similar configurations or any suitable combinations thereof.While specific examples are provided above, it should be understood thatthey are not intended to be an exhaustive list of configurations. Otherconfigurations may be possible. Moreover, various terms can be used todescribe the same or substantially similar configurations and thus, theuse of particular terms are not intended to be limiting and/or to theexclusion of other terms unless the terms and/or configurations aremutually exclusive, or the context clearly states otherwise.

In general, traditional delivery of prosthetic valves can be such that acentral cylinder axis of the valve is substantially parallel to alengthwise axis of a delivery catheter used to deliver the valve.Typically, the valves are compressed in a radial direction relative tothe central cylinder axis and advanced through the lumen of the deliverycatheter. The valves are deployed from the end of the delivery catheterand expanded outwardly in a radial direction from the central cylinderaxis. The delivery orientation of the valve generally means that thevalve is completely released from the delivery catheter while in theatrium of the heart and reoriented relative to the annulus, which insome instances, can limit a size of the valve.

The prosthetic valves described herein are configured to be deliveredvia side or orthogonal delivery techniques, unless clearly statedotherwise. As used herein the terms “side-delivered,” “side-delivery,”“orthogonal delivery,” “orthogonally delivered,” and/or so forth can beused interchangeably to describe such a delivery method and/or a valvedelivered using such a method. Orthogonal delivery of prosthetic valvescan be such that the central cylinder axis of the valve is substantiallyorthogonal to the lengthwise axis of the delivery catheter. Withorthogonal delivery, the valves are compressed (or otherwise reduced insize) in a direction substantially parallel to the central cylinder axisand/or in a lateral direction relative to the central cylinder axis. Assuch, a lengthwise axis (e.g., a longitudinal axis) of an orthogonallydelivered valve is substantially parallel to the lengthwise axis of thedelivery catheter. In other words, an orthogonally delivered prostheticvalve is compressed and/or delivered at a roughly 90-degree anglecompared to traditional processes of compressing and deliveringtranscatheter prosthetic valves. Moreover, in some instances, theorientation of orthogonally delivered valves relative to the annulus canallow a distal portion of the valve to be at least partially insertedinto the annulus of the native heart valve while the proximal portion ofthe valve, at least in part, remains in the delivery catheter, therebyavoiding at least some of the size constraints faced with some knowtraditional delivery techniques. Examples of prosthetic valvesconfigured to be orthogonally delivered and processes of delivering suchvalves are described in detail in the '957 PCT and/or the '010 PCTincorporated by reference hereinabove.

Mathematically, the term “orthogonal” refers to an intersecting angle of90 degrees between two lines or planes. As used herein, the term“substantially orthogonal” refers to an intersecting angle of 90 degreesplus or minus a suitable tolerance. For example, “substantiallyorthogonal” can refer to an intersecting angle ranging from 75 to 105degrees.

The embodiments herein, and/or the various features or advantageousdetails thereof, are explained more fully with reference to thenon-limiting embodiments that are illustrated in the accompanyingdrawings and detailed in the following description. Descriptions ofwell-known components and processing techniques are omitted so as to notunnecessarily obscure the embodiments herein. Like numbers refer to likeelements throughout.

A discussion of various embodiments, components, and/or features of aprosthetic valve is followed by a discussion of delivery and/orretrieval systems used to delivery, deploy, and/or at least partiallyretrieve such prosthetic valves. The examples and/or embodimentsdescribed herein are intended to facilitate an understanding ofstructures, functions, and/or aspects of the embodiments, ways in whichthe embodiments may be practiced, and/or to further enable those skilledin the art to practice the embodiments herein. Similarly, methods and/orways of using the embodiments described herein are provided by way ofexample only and not limitation. Specific uses described herein are notprovided to the exclusion of other uses unless the context expresslystates otherwise. For example, any of the prosthetic valves describedherein can be used to replace a native valve of a human heart including,for example, a mitral valve, a tricuspid valve, an aortic valve, and/ora pulmonary valve. While some prosthetic valves are described herein inthe context of replacing a native mitral valve or a native tricuspidvalve, it should be understood that such a prosthetic valve can be usedto replace any native valve unless expressly stated otherwise or unlessone skilled in the art would clearly recognize that one or morecomponents and/or features would otherwise make the prosthetic valveincompatible for such use. Accordingly, specific examples, embodiments,methods, and/or uses described herein should not be construed aslimiting the scope of the inventions or inventive concepts herein.Rather, examples and embodiments are provided so that this disclosurewill be thorough and complete, and will fully convey the scope of theinventive concepts to those skilled in the art.

FIGS. 1A-1E are various schematic illustrations of a transcatheterprosthetic valve 100 according to an embodiment. The transcatheterprosthetic valve 100 is configured to be deployed in a desired locationwithin a body (e.g., of a human patient) and to permit blood flow in afirst direction through an inflow end of the transcatheter prostheticvalve 100 and to block blood flow in a second direction, opposite thefirst direction, through an outflow end of the transcatheter prostheticvalve 100. For example, the transcatheter prosthetic valve 100 can be atranscatheter prosthetic heart valve configured to be deployed withinthe annulus of a native tricuspid valve or native mitral valve of ahuman heart to supplement and/or replace the functioning of the nativevalve.

The transcatheter prosthetic valve 100 (also referred to herein as“prosthetic valve” or simply “valve”) is compressible and expandable inat least one direction relative to a long-axis 102 of the valve 100(also referred to herein as “horizontal axis,” “longitudinal axis,” or“lengthwise axis”). The valve 100 is compressible and expandable betweenan expanded configuration (FIGS. 1A, 1C, and 1E) for implanting at adesired location in a body (e.g., a human heart) and a compressed ordelivery configuration (FIGS. 1B and 1D) for introduction into the bodyusing a delivery catheter.

In some embodiments, the valve 100 (and/or at least a portion thereof)may start in a roughly tubular configuration and may be heat-shapedand/or otherwise formed into any desired shape. In some embodiments, thevalve 100 can include an upper atrial cuff or flange for atrial sealing,a lower ventricle cuff or flange for ventricular sealing, and atransannular section or region (e.g., a body section, a tubular section,a cylindrical section, etc.) disposed therebetween. The transannularregion can have an hourglass cross-section for about 60-80% of thecircumference to conform to the native annulus along the posterior andanterior annular segments while remaining substantially vertically flatalong 20-40% of the annular circumference to conform to the septalannular segment. While the valve 100 is shown in FIGS. 1A-1E as having agiven shape, it should be understood that the size and/or shape of thevalve 100 (and/or at least a portion thereof) can be based on a sizeand/or shape of the anatomical structures of the native tissue.

For example, the valve 100 can be centric (e.g., radially symmetricalrelative to a central y-axis 104), or can be eccentric (e.g., radiallyasymmetrical relative to the central y-axis axis 104). In some eccentricembodiments, the valve 100, or an outer frame thereof, may have acomplex shape determined by the anatomical structures where the valve100 is being mounted. For example, in some instances, the valve 100 maybe deployed in the tricuspid annulus having a circumference in the shapeof a rounded ellipse with a substantially vertical septal wall, andwhich is known to enlarge in disease states along an anterior-posteriorline. In some instances, the valve 100 may be deployed in the mitralannulus (e.g., near the anterior leaflet) having a circumference in theshape of a rounded ellipse with a substantially vertical septal wall,and which is known to enlarge in disease states. As such, the valve 100can have a complex shape that determined, at least in part, by thenative annulus and/or a disease state of the native valve. For example,in some such embodiments, the valve 100 or the outer frame thereof mayhave a D-shape (viewed from the top) so the flat portion can be matchedto the anatomy in which the valve 100 will be deployed.

As shown, the valve 100 generally includes an annular support frame 110and a flow control component 150. In addition, the valve 100 and/or atleast the annular support frame 110 of the valve 100 can include and/orcan couple to an actuator 170 and/or a delivery system interface 180. Insome implementations, the valve 100 and/or aspects or portions thereofcan be similar to and/or substantially the same as the valves (and/orthe corresponding aspects or portions thereof) described in detail inthe '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT,the '327 Provisional, the '964 Provisional, the '345 Provisional, and/orthe '807 Provisional incorporated by reference hereinabove. Accordingly,certain aspects, portions, and/or details of the valve 100 may not bedescribed in further detail herein.

The annular support frame 110 (also referred to herein as “tubularframe,” “valve frame,” “wire frame,” “outer frame,” or “frame”) can havea supra-annular region 120, a subannular region 130, and a transannularregion 112, disposed and/or coupled therebetween. In some embodiments,the supra-annular region 120, the subannular region 130, and thetransannular region 112 can be separate, independent, and/or modularcomponents that are coupled to collectively form the frame 110. In someimplementations, such a modular configuration can allow the frame 110 tobe adapted to a given size and/or shape of the anatomical structureswhere the valve 100 is being mounted. For example, one or more of thesupra-annular region(s) 120, the subannular region 130, and/or thetransannular region 112 can be designed and/or adapted so that that thesupport frame has any desirable height, outer diameter, and/or innerdiameter such as any of those described above. Moreover, such a modularconfiguration can allow the frame 110 to bend, flex, compress, fold,roll, and/or otherwise reconfigure without plastic or permanentdeformation thereof. For example, the frame 110 is compressible to acompressed configuration for delivery and when released it is configuredto return to its original shape (uncompressed or expandedconfiguration).

The support frame 110 and/or the supra-annular region 120, subannularregion 130, and/or transannular region 112 can be formed from or of anysuitable material. In some embodiments, the supra-annular region 120,the subannular region 130, and the transannular region 112 can be formedfrom or of a shape-memory or superelastic metal, metal alloy, plastic,and/or the like. For example, the supra-annular region 120, thesubannular region 130, and the transannular region 112 can be formedfrom or of Nitinol or the like. Moreover, the supra-annular region 120,the subannular region 130, and the transannular region 112 can becoupled to from a wire frame portion of the support frame 110, which inturn, is covered by a biocompatible material such as, for example,pericardium tissue (e.g., Duraguard®, Peri-Guard®, Vascu-Guard®, etc.),polymers (e.g., polyester, Dacron®, etc.), and/or the like, as describedabove.

The supra-annular region 120 of the frame 110 can be and/or can form,for example, a cuff or collar that can be attached or coupled to anupper edge or upper portion of the transannular region 112, as describedin further detail herein. When the valve 100 is deployed within a humanheart, the supra-annular region 120 can be an atrial collar that isshaped to conform to the native deployment location. In a tricuspidand/or mitral valve replacement, for example, the supra-annular region120 collar can have various portions configured to conform to the nativevalve and/or a portion of the atrial floor surrounding the tricuspidand/or mitral valve, respectively. In some implementations, thesupra-annular region 120 can be deployed on the atrial floor to directblood from the atrium into the flow control component 150 of the valve100 and to seal against blood leakage (perivalvular leakage) around theframe 110.

In some embodiments, the supra-annular region 120 can be a wire framethat is laser cut out of any suitable material. In some embodiments, thesupra-annular region 120 can be formed from a shape-memory orsuperelastic material such as, for example, Nitinol. In someembodiments, the supra-annular region 120 can be laser cut from a sheetof a shape-memory metal alloy such as Nitinol and, for example, heat-setinto a desired shape and/or configuration. In some embodiments, formingthe supra-annular region 120 in such a manner can allow thesupra-annular region 120 to bend, flex, fold, compress, and/or otherwisereconfigure substantially without plastically deforming and/or withoutfatigue that may result in failure or breaking of one or more portionsthereof. Moreover, the wire frame of the supra-annular region 120 can becovered by any suitable biocompatible material such as any of thosedescribed above.

As shown in FIG. 1A, the supra-annular region 120 includes a distalportion 122 and a proximal portion 124. In some embodiments, the distalportion 122 can be and/or can include a distal supra-annular anchoringelement and/or the like that can engage native tissue on a distal sideof the annulus as the prosthetic valve 100 is seated into the annulus.In some embodiments, the proximal portion 124 can be and/or can includea proximal supra-annular anchoring element and/or the like that canengage native tissue on a proximal side of the annulus as the prostheticvalve 100 is seated in the annulus. In some embodiments, the distalportion 122 and/or the distal supra-annular anchoring element can besized and/or shaped to correspond to a size and/or shape of the distalportion of the atrial floor of the heart in which the prosthetic valve100 is disposed. Similarly, the proximal portion 124 and/or the proximalsupra-annular anchoring element can be sized and/or shaped to correspondto a size and/or shape of a proximal portion of the atrial floor of theheart.

Although not shown in FIGS. 1A-1E, the supra-annular region 120 can beshaped and/or formed to include any number of features configured toengage native tissue and/or one or more other portions of the valve 100,the actuator 170, and/or the delivery system interface 180. For example,in some embodiments, the supra-annular region 120 can include and/or canform an outer portion, an inner portion, and one or more splinesdisposed between the outer portion and the inner portion. In someimplementations, the outer portion can be sized and/or shaped to engagenative tissue, the inner portion can provide structure for mounting theflow control component 150 to the support frame 110, and the one or moresplines can receive, couple to, and/or otherwise engage the actuator 170and/or the delivery system interface 180, as described in further detailherein with reference to specific embodiments.

The subannular region 130 of the frame 110 can be and/or can form, forexample, a cuff or collar that can be attached or coupled to a loweredge or upper portion of the transannular region 112, as described infurther detail herein. When the valve 100 is deployed within a humanheart, the subannular region 130 can be a ventricular collar that isshaped to conform to the native deployment location. In a tricuspidand/or mitral valve replacement, for example, the subannular region 130or collar can have various portions configured to conform to the nativevalve and/or a portion of the ventricular ceiling surrounding thetricuspid and/or mitral valve, respectively. In some implementations,the subannular region 130 or at least a portion thereof can engage theventricular ceiling surrounding the native annulus to secure the valve100 in the native annulus, to prevent dislodging of the valve 100, tosandwich or compress the native annulus or adjacent tissue between thesupra-annular region 120 and the subannular region 130, and/or to sealagainst blood leakage (perivalvular leakage and/or regurgitation duringsystole) around the frame 110.

In some embodiments, the subannular region 130 can be a wire frame thatis laser cut out of any suitable material. In some embodiments, thesubannular region 130 can be formed from a shape-memory or superelasticmaterial such as, for example, Nitinol. In some embodiments, thesubannular region 130 can be laser cut from a sheet of a shape-memorymetal alloy such as Nitinol and, for example, heat-set into a desiredshape and/or configuration. In some embodiments, forming the subannularregion 130 in such a manner can allow the subannular region 130 to bend,flex, fold, compress, and/or otherwise reconfigure substantially withoutplastically deforming and/or without fatigue that may result in failureor breaking of one or more portions thereof. Moreover, the wire frame ofthe subannular region 130 can be covered by any suitable biocompatiblematerial such as any of those described above.

The subannular region 130 can be shaped and/or formed to include anynumber of features configured to engage native tissue, one or more otherportions of the valve 100, and/or the actuator 170. For example, in someembodiments, the subannular region 130 can include and/or can form adistal portion having a distal anchoring element 132 and a proximalportion having a proximal anchoring element 134. In some embodiments,the subannular region 130 can include and/or can form any other suitableanchoring element (not shown in FIGS. 1A-1E). In some embodiments, theanchoring elements 132 and 134 are integrally and/or monolithicallyformed with the subannular region 130. The distal anchoring element 132and the proximal anchoring element 134 of the subannular region 130 canbe any suitable shape, size, and/or configuration such as any of thosedescribed in detail in the '957 PCT, the '010 PCT, the '231 PCT, the'390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the'345 Provisional, and/or the '807 Provisional, and/or any of thosedescribed herein with respect to specific embodiments. For example, theanchoring elements 132 and 134 can extend from a portion of thesubannular region 130 by about 10-40 mm.

In some embodiments, the distal anchoring element 132 can optionallyinclude a guidewire coupler configured to selectively engage and/orreceive a portion of a guidewire or a portion of a guidewire assembly.The guidewire coupler is configured to allow a portion of the guidewireto extend through an aperture of the guidewire coupler, thereby allowingthe valve 100 to be advanced over or along the guidewire during deliveryand deployment. In some embodiments, the guidewire coupler canselectively allow the guidewire to be advanced therethrough whileblocking or preventing other elements and/or components such as a pusheror the like.

The anchoring elements 132 and/or 134 of the subannular region 130 canbe configured to engage a desired portion of the native tissue to mountthe valve 100 and/or the support frame 110 to the annulus of the nativevalve in which it is deployed. For example, in some implementations, thedistal anchoring element 132 can be a projection or protrusion extendingfrom the subannular region 130 and into a RVOT or a LVOT. In suchimplementations, the distal anchoring element 132 can be shaped and/orbiased such that the distal anchoring element 132 exerts a force on thesubannular tissue operable to at least partially secure the distal endportion of the valve 100 in the native annulus. In some implementations,the proximal anchoring element 134 can be configured to engagesubannular tissue on a proximal side of the native annulus to aid in thesecurement of the valve 100 in the annulus.

In some implementations, at least the proximal anchoring element 134 canbe configured to transition, move, and/or otherwise reconfigure betweena first configuration in which the proximal anchoring element 134extends from the subannular region 130 a first amount or distance and asecond configuration in which the proximal anchoring element 134 extendsfrom the subannular region 130 a second amount or distance. For example,in some embodiments, the proximal anchoring element 134 can have a firstconfiguration in which the proximal anchoring element 134 is in acompressed, contracted, retracted, undeployed, folded, and/or restrainedstate (e.g., a position that is near, adjacent to, and/or in contactwith the transannular region 112 and/or the supra-annular region 120 ofthe support frame 110), and a second configuration in which the proximalanchoring element 134 is in an expanded, extended, deployed, unfolded,and/or unrestrained state (e.g., extending away from the transannularregion 112). Moreover, in some implementations, the proximal anchoringelement 134 can be transitioned in response to actuation of the actuator170, as described in further detail herein.

In some implementations, the proximal anchoring element 134 can betransitioned from the first configuration to the second configurationduring deployment to selectively engage native tissue, chordae,trabeculae, annular tissue, leaflet tissue, and/or any other anatomicstructures to aid in the securement of the valve 100 in the nativeannulus. The proximal anchoring element 134 (and/or the distal anchoringelement 132) can include any suitable feature, surface, member, etc.configured to facilitate the engagement between the proximal anchoringelement 134 (and/or the distal anchoring element 132) and the nativetissue. For example, in some embodiments, the proximal anchoring element134 can include one or more features configured to engage and/or becomeentangled in the native tissue, chordae, trabeculae, annular tissue,leaflet tissue, and/or any other anatomic structures when in the secondconfiguration, as described in further detail herein with reference tospecific embodiments.

The transannular region 112 of the support frame 110 is disposed betweenthe supra-annular region 120 and the subannular region 130. In someembodiments, the transannular region 112 can be coupled to each of thesupra-annular region 120 and the subannular region 130 such that adesired amount of movement and/or flex is allowed therebetween (e.g.,welded, bonded, sewn, bound, and/or the like). For example, in someimplementations, the transannular region 112 and/or portions thereof canbe sewn to each of the supra-annular region 120 and the subannularregion 130 (and/or portions thereof).

The transannular region 112 can be shaped and/or formed into a ring, acylindrical tube, a conical tube, D-shaped tube, and/or any othersuitable annular shape. In some embodiments, the transannular region 112may have a side profile of a flat-cone shape, an inverted flat-coneshape (narrower at top, wider at bottom), a concave cylinder (walls bentin), a convex cylinder (walls bulging out), an angular hourglass, acurved, graduated hourglass, a ring or cylinder having a flared top,flared bottom, or both. Moreover, the transannular region 112 can formand/or define an aperture or central channel 114 that extends along thecentral axis 104 (e.g., the y-axis). The central channel 114 (e.g., acentral axial lumen or channel) can be sized and configured to receivethe flow control component 150 across a portion of a diameter of thecentral channel 114. In some embodiments, the transannular region 112can have a shape and/or size that is at least partially based on a size,shape, and/or configuration of the supra-annular region 120 and/orsubannular region 130 of the support frame 110, and/or the nativeannulus in which it is configured to be deployed. For example, thetransannular region 112 can have an outer circumference surface forengaging native annular tissue that may be tensioned against an inneraspect of the native annulus to provide structural patency to a weakenednative annular ring.

In some embodiments, the transannular region 112 can be a wire framethat is laser cut out of any suitable material. In some embodiments, thetransannular region 112 can be formed from a shape-memory orsuperelastic material such as, for example, Nitinol. In someembodiments, the transannular region 112 can be laser cut from a sheetof a shape-memory metal alloy such as Nitinol and, for example, heat-setinto a desired shape and/or configuration. Although not shown in FIGS.1A-1E, in some embodiments, the transannular region 112 can includeand/or can be formed with two laser cut halves that can be formed into adesired shape and/or configuration and coupled together to form thetransannular region 112. The transannular region 112 can be formed toinclude a set of compressible wire cells having an orientation and/orcell geometry substantially orthogonal to the central axis 104 (FIG. 1A)to minimize wire cell strain when the transannular region 112 is in avertical compressed configuration, a rolled and compressedconfiguration, or a folded and compressed configuration. In someembodiments, forming the transannular region 112 in such a manner canallow the transannular region 112 to bend, flex, fold, deform, and/orotherwise reconfigure (substantially without plastic deformation and/orundue fatigue) in response to lateral folding along or in a direction ofa lateral axis 106 (FIG. 1C) and/or vertical compression along or in adirection of the central axis 104 (FIG. 1D), as described in furtherdetail herein.

As described above with reference to the supra-annular region 120 andthe subannular region 130, the wire frame of the transannular region 112can be covered by any suitable biocompatible material such as any ofthose described above. In some implementations, the wire frames of thesupra-annular region 120, transannular region 112, and subannular region130 can be flexibly coupled (e.g., sewn) to form a wire frame portion ofthe support frame 110, which in turn, is covered in the biocompatiblematerial. Said another way, the supra-annular region 120, thetransannular region 112, and the subannular region 130 can be coveredwith the biocompatible material prior to being coupled or after beingcoupled. In embodiments in which the wire frames are covered after beingcoupled, the biocompatible material can facilitate and/or support thecoupling therebetween.

Although not shown in FIGS. 1A-1E, the frame 110 may also have and/orform additional functional elements (e.g., loops, anchors, etc.) forattaching accessory components such as biocompatible covers, tissueanchors, releasable deployment and retrieval controls (e.g., theactuator 170, the delivery system interface 180, and/or other suitableguides, knobs, attachments, rigging, etc.) and so forth. In someimplementations, the frame 110 (or aspects and/or portions thereof) canbe structurally and/or functionally similar to the frames (orcorresponding aspects and/or portions thereof) described in detail inthe '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT,the '327 Provisional, the '964 Provisional, the '345 Provisional, and/orthe '807 Provisional.

The flow control component 150 can refer in a non-limiting sense to adevice for controlling fluid flow therethrough. In some embodiments, theflow control component 150 can be a leaflet structure having 2-leaflets,3-leaflets, 4-leaflets, or more, made of flexible biocompatible materialsuch a treated or untreated pericardium. The leaflets can be sewn orjoined to a support structure such as an inner frame, which in turn, canbe sewn or joined to the outer frame 110. The leaflets can be configuredto move between an open and a closed or substantially sealed state toallow blood to flow through the flow control component 150 in a firstdirection through an inflow end of the valve 100 and block blood flow ina second direction, opposite to the first direction, through an outflowend of the valve 100. For example, the flow control component 150 can beconfigured such that the valve 100 functions, for example, as a heartvalve, such as a tricuspid valve, mitral valve, aortic valve, orpulmonary valve, that can open to blood flowing during diastole fromatrium to ventricle, and that can close from systolic ventricularpressure applied to the outer surface. Repeated opening and closing insequence can be described as “reciprocating.”

The inner frame and/or portions or aspects thereof can be similar in atleast form and/or function to the outer frame 110 and/or portions oraspects thereof. For example, the inner frame can be a laser cut wireframe formed from or of a shape-memory material such as Nitinol.Moreover, the inner frame can be compressible for delivery andconfigured to return to its original (uncompressed) shape when released(e.g., after delivery). In some embodiments, the inner frame can includeand/or can form any suitable number of compressible, elasticallydeformable diamond-shaped or eye-shaped wire cells, and/or the like. Thewire cells can have an orientation and cell geometry substantiallyorthogonal to an axis of the flow control component 150 to minimize wirecell strain when the inner frame is in a compressed configuration.

In some embodiments, the flow control component 150 and/or the innerframe thereof can have a substantially cylindrical or tubular shape whenthe valve 100 is in the expanded configuration (see e.g., FIG. 1C) andcan be configured to elastically deform when the valve 100 is placed inthe compressed configuration (see e.g., FIGS. 1B and 1D). Although notshown in FIGS. 1A-1E, in some embodiments, the inner frame of the flowcontrol component 150 can include and/or can be formed with two halvesthat can be coupled together to allow the inner frame to elasticallydeform in response to lateral compression or folding along or in adirection of the lateral axis 106 (FIG. 1C), as described in furtherdetail herein.

As shown in FIGS. 1A-1D, the flow control component 150 is mountedwithin the central channel 114 of the frame 110. More specifically, theflow control component 150 is mounted and/or coupled to thesupra-annular region 120 (e.g., an inner portion thereof) and isconfigured to extended into and/or through the central channel 114formed and/or defined by the transannular region 112. In someembodiments, the flow control component 150 can be coupled to thesupra-annular region 120 via tissue, a biocompatible mesh, one or morewoven or knitted fabrics, one or more superelastic or shape-memory alloystructures, which is sewn, sutured, and/or otherwise secured to aportion supra-annular region 120. In some embodiments, the flow controlcomponent 150 can be coupled to the supra-annular region 120 such that aportion of the flow control component 150 is disposed above and/orotherwise extends beyond the supra-annular region 120 (e.g., extendsaway from the annulus in the direction of the atrium). In someembodiments, the portion of the flow control component 150 extendingabove and/or beyond the supra-annular region 120 can form a ridge,ledge, wall, step-up, and/or the like. In some implementations, such anarrangement can facilitate ingrowth of native tissue over thesupra-annular region 120 without occluding the flow control component150.

The flow control component 150 can be at least partially disposed in thecentral channel 114 such that the axis of the flow control component 150that extends in the direction of blood flow through the flow controlcomponent 150 is substantially parallel to the central axis 104 of theframe 110. In some embodiments, the arrangement of the support frame 110can be such that the flow control component 150 is centered within thecentral channel 114. In other embodiments, the arrangement of thesupport frame 110 can be such that the flow control component 150 is offcentered within the central channel 114. In some embodiments, thecentral channel 114 can have a diameter and/or perimeter that is largerthan a diameter and/or perimeter of the flow control component 150.Although not shown in FIGS. 1A-1E, in some embodiments, the valve 100can include a spacer or the like that can be disposed within the centralchannel 114 adjacent to the flow control component 150. In otherembodiments, a spacer can be a cover, or the like coupled to a portionof the frame 110 and configured to cover a portion of the centralchannel 114. In some instances, the spacer can be used to facilitate thecoupling of the flow control component 150 to the frame 110.

In some embodiments, the flow control component 150 (or portions and/oraspects thereof) can be similar to, for example, any of the flow controlcomponents described in the '231 PCT. Thus, the flow control component150 and/or aspects or portions thereof are not described in furtherdetail herein.

Referring back to FIG. 1A, the valve 100 includes and/or is coupled tothe actuator 170 and the delivery interface 180. The actuator 170 can beany suitable member, mechanism, and/or device configured to actuate atleast a portion of the valve 100. For example, in some embodiments, theactuator 170 and/or a portion of the actuator 170 can be configured toat least temporarily couple to the supra-annular region 120 of thesupport frame 110 (e.g., a spline and/or other portion thereof) and canbe configured to actuate one or more portions of the valve 100. Morespecifically, the actuator 170 can be configured to actuate at least theproximal anchoring element 134 of the subannular region 120 of thesupport frame 110 to transition the proximal anchoring element 134between its first and second configurations. In some implementations,the actuator 170 can include one or more cables, tethers, linkages,joints, connections etc., that can exert a force (or can remove anexerted force) on a portion of the proximal anchoring element 134operable to transition the proximal anchoring element 134 between thefirst and second configuration. For example, the subannular region 130of the support frame 110 can be formed with the proximal anchoringelement 134 biased in the uncompressed and/or expanded configuration andthe actuator 170 can be actuated to exert a force, via the one or morecables, tethers, etc., operable to transition the proximal anchoringelement 134 to the compressed and/or retracted configuration.

In some implementations, the actuator 170 can be secured and/or lockedwhen the proximal anchoring element 134 is compressed and/or retracted(e.g., a first configuration) to at least temporarily maintain theproximal anchoring element 134 in the first configuration. As describedabove, in some implementations, the proximal anchoring element 134 canbe in the first configuration for delivery and deployment prior toseating the valve 100 in the native annulus. Once the valve 100 isseated in the native annulus, a user can manipulate a portion of thedelivery system to actuate the actuator 170. In this example, actuatingthe actuator 170 can cause the actuator 170 to release and/or remove theforce exerted on the proximal anchoring element 134 (e.g., via thecable(s), tether(s), etc.), thereby allowing the proximal anchoringelement 134 to return to its original or biased configuration (e.g., asecond configuration), as described above.

The delivery system interface 180, shown in FIG. 1A, can include anynumber of components having any suitable shape, size, and/orconfiguration. In some implementations, the delivery system interface180 can be and/or can include, for example, a distal end portion of thedelivery system used to deliver the valve 100 to a desired location inthe body of a patient (e.g., the annulus of a native heart valve). Insome embodiments, the delivery system interface can include a deliverycatheter such as, for example, a 12-34 Fr delivery catheter with anysuitable corresponding internal lumen diameter sufficient to receive theprosthetic valve 100 in the compressed configuration, as described, forexample, in the '957 PCT. Moreover, the delivery system can include asecondary catheter that can be, for example, a multi-lumen catheterconfigured to engage the valve 100 to advance the valve 100 through thedelivery catheter. In some embodiments, each lumen of the multi-lumensecondary catheter can include, for example, a cable, tether, and/or anyother suitable component associated with and/or included in the actuator170. Each cable, tether, and/or component can, in turn, be coupled to aportion of the valve 100 or support frame 110 and configured to actuatea portion thereof, as described in further detail herein with referenceto specific embodiments.

Furthermore, a lumen of the multi-lumen secondary catheter (e.g., acentral lumen) can include and/or can receive a torque cable and aguidewire. The guidewire extends though the secondary catheter and intoa desired position relative to the native tissue (e.g., the RVOT or theLVOT) to provide a path along which the valve 100 travels duringdelivery and/or deployment, as described in the '957 PCT. The torquecable can be any suitable cable, or the like configured to removablycouple to the supra-annular region 120 of the frame 110 (e.g., awaypoint coupled to and/or formed by the supra-annular region 120). Thetorque cable can be a relatively stiff cable that can be configured tofacilitate delivery and/or deployment of the valve 100 as well asretraction of the valve 100 if desirable. In this manner, the deliverysystem interface 180 shown in FIG. 1A, can be a distal end portion ofthe delivery system including any of the components described above.Thus, the delivery system interface 180 can be used in and/or otherwisecan facilitate the delivery of the valve 100, deployment and/oractuation of the valve 100 or a portion thereof (e.g., the proximalanchoring element 134), and/or retraction of the valve 100. Moreover,the delivery system interface 180 can be configured to decouple,disengage, and/or otherwise release the valve 100 after the valve 100 isdeployed in a native annulus, as described in further detail herein withreference to specific embodiments.

As described above, the valve 100 is compressible and expandable betweenthe expanded configuration and the compressed configuration. The valve100 can have a first height or size along the central axis 104 when inthe expanded configuration and can have a second height or size, lessthan the first height or size, along the central axis 104 when in thecompressed configuration. The valve 100 can also be compressed inadditional directions. For example, the valve 100 can be compressedalong the lateral axis 106 that is perpendicular to both thelongitudinal axis 102 and the central axis 104 (see e.g., FIGS. 1B and1C).

The valve 100 is compressed during delivery of the valve 100 and isconfigured to expand once released from the delivery catheter. Morespecifically, the valve 100 is configured for transcatheter orthogonaldelivery to the desired location in the body (e.g., the annulus of anative valve), in which the valve 100 is compressed in an orthogonal orlateral direction relative to the dimensions of the valve 100 in theexpanded configuration (e.g., along the central axis 104 and/or thelateral axis 106). During delivery, the longitudinal axis 102 of thevalve 100 is substantially parallel to a longitudinal axis of thedelivery catheter, as described in the '957 PCT.

The valve 100 is in the expanded configuration prior to being loadedinto the delivery system and after being released from the deliverycatheter and deployed or implanted (or ready to be deployed orimplanted) at the desired location in the body. When in the expandedconfiguration shown in FIGS. 1A, 1B, and 1E, the valve 100 has an extentin any direction orthogonal or lateral to the longitudinal axis 102(e.g., along the central axis 104 and/or the lateral axis 106) that islarger than a diameter of the lumen of the delivery catheter used todeliver the valve 100. For example, in some embodiments, the valve 100can have an expanded height (e.g., along the central axis 104) of 5-60mm. In some embodiments, the valve 100 can have an expanded diameterlength (e.g., along the longitudinal axis 102) and width (e.g., alongthe lateral axis 106) of about 20-80 mm, or about 40-80 mm.

When in the compressed configuration shown in FIGS. 1C and 1D, the valve100 has an extent in any direction orthogonal or lateral to thelongitudinal axis 102 (e.g., along the central axis 104 and/or thelateral axis 106) that is smaller than the diameter of the lumen of thedelivery catheter, allowing the valve 100 to be delivered therethrough.For example, in some embodiments, the valve 100 can have a compressedheight (e.g., along the central axis 104) and a compressed width (e.g.,along the lateral axis 106) of about 6-15 mm, about 8-12 mm, or about9-10 mm. The valve 100 can be compressed by compressing, rolling,folding, and/or any other suitable manner, or combinations thereof, asdescribed in detail in the '957 PCT, the '010 PCT, the '231 PCT, the'390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the'345 Provisional, and/or the '807 Provisional. It is contemplated insome embodiments that the length of the valve 100 (e.g., along thelongitudinal axis 102) is not compressed for delivery. Rather, in someembodiments, the length of the valve 100 can be increased in response tocompression of the valve 100 along the central axis 104 and/or thelateral axis 106.

As shown in FIG. 1E, the valve 100 can be delivered, for example, to anatrium of the human heart and disposed within an annulus of a nativevalve such as, for example, the pulmonary valve (PV), the mitral valve(MV), the aortic valve (AV), and/or the tricuspid valve (TV). Asdescribed above, the valve 100 can be in the compressed configurationand delivered to the annulus via the delivery system and can be releasedfrom the delivery system and allowed to expand to the expandedconfiguration. For example, the valve 100 can be delivered to the atriumof the human heart and released from the delivery catheter (not shown)via any of the delivery systems, devices, and/or methods described indetail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the'108 PCT, the '327 Provisional, the '964 Provisional, the '345Provisional, and/or the '807 Provisional.

In some implementations, the delivery of the valve 100 can includeadvancing a guidewire into the atrium of the human heart, through thenative valve, and to a desired position within the ventricle (e.g., theRVOT or the LVOT). After positioning the guidewire, the deliverycatheter can be advanced along and/or over the guidewire and into theatrium (e.g., via the IVC, the SVC, and/or a trans-septal access). Insome embodiments, a guidewire coupler of the valve 100 (e.g., includedin or on the distal anchoring element 132) can be coupled to a proximalend portion of the guidewire and the valve 100 can be placed in thecompressed configuration, allowing the valve 100 to be advanced alongthe guidewire and through a lumen of the delivery catheter, and into theatrium.

The deployment of the valve 100 can include placing the distal anchoringelement 132 of the subannular region 130 in the ventricle (RV, LV) belowthe annulus while the remaining portions of the valve 100 are in theatrium (RA, LA). In some instances, the distal anchoring element 132 canbe advanced over and/or along the guidewire to a desired position withinthe ventricle such as, for example, an outflow tract of the ventricle.For example, in some implementations, the valve 100 can be delivered tothe annulus of the native tricuspid valve (TV) and at least a portion ofthe distal anchoring element 132 can be positioned in the RVOT. In otherimplementations, the valve 100 can be delivered to the annulus of thenative mitral valve (MV) and at least a portion of the distal anchoringelement 132 can be positioned in the LVOT.

In some implementations, the prosthetic valve 100 can be temporarilymaintained in a partially deployed state. For example, the valve 100 canbe partially inserted into the annulus and held at an angle relative tothe annulus to allow blood to flow from the atrium to the ventriclepartially through the native valve annulus around the valve 100, andpartially through the valve 100, which can allow for assessment of thevalve function.

The valve 100 can be placed or seated in the annulus (PVA, MVA, AVA,and/or TVA) of the native valve (PV, MV, AV, and/or TV) such that thesubannular region 130 (e.g., a ventricular collar) is disposed in asubannular position, the transannular region 112 of the valve frame 110extends through the annulus, and the supra-annular region 120 (e.g., anatrial collar) remains in a supra-annular position. For example, in someembodiments, the delivery system, the delivery system interface 180, theactuator 170, and/or any other suitable member, tool, etc. can be usedto push at least the proximal end portion of the valve 100 into theannulus. In some implementations, the proximal anchoring element 134 canbe maintained in its first configuration as the valve 100 is seated inthe annulus. For example, as described above, the proximal anchoringelement 134 can be in a compressed, contracted, and/or retractedconfiguration in which the proximal anchoring element 134 is in contactwith, adjacent to, and/or near the transannular region 112 and/or thesupra-annular region 120 of the frame 110, which in turn, can limit anoverall circumference of the subannular region 130 of the frame 110,thereby allowing the subannular region 130 and the transannular region112 of the frame 110 to be inserted into and/or through the annulus.

Once seated, the proximal anchoring element 134 can be transitioned fromits first configuration to its second configuration, as described indetail in the '010 PCT, the '108 PCT, and/or the '345 Provisional. Forexample, in some implementations, a user can manipulate a portion of thedelivery system to actuate the actuator 170. In some implementations,actuating the actuator 170 can release and/or reduce an amount oftension within or more tethers, cables, connections, and/or portions ofthe actuator 170, thereby allowing the proximal anchoring element 134 totransition Accordingly, once the valve 100 is seated in the annulus, theproximal anchoring element 134 can be placed in its second configurationin which the proximal anchoring element 134 contacts, engages, and/or isotherwise disposed adjacent to subannular tissue. In someimplementations, the proximal anchoring element 134 can be configured toengage and/or capture native tissue, chordae, trabeculae, annulartissue, leaflet tissue, and/or the like when the proximal anchoringelement 134 is disposed in the ventricle. For example, in someimplementations, after seating the valve 100 in the annulus, theproximal anchoring element 134 can be transitioned from the first(compressed) configuration to the second (extended) configuration suchthat the proximal anchoring element 134 extends around and/or throughone or more portions of native tissue, chordae, etc. The proximalanchoring element 134 can then be returned to the first configuration tocapture and/or secure the one or more portions of native tissue,chordae, trabeculae, annular tissue, leaflet tissue, etc. between theproximal anchoring element 134 and, for example, the transannularsection of the outer frame 110. In other implementations, the proximalanchoring element 134 can be maintained in the second (extended)configuration after the valve 100 is seated in the native annulus. Insuch implementations, the proximal anchoring element 134, for example,can contact and/or engage subannular tissue on a proximal side of theannulus such that the proximal anchoring element and a proximal portionof the atrial collar exert a compressive force on a proximal portion ofthe annular tissue.

In this manner, the distal anchoring element 132 can be configured toengage native tissue on a distal side of the annulus and the proximalanchoring element 134 can be configured to engage native tissue on aproximal side of the annulus (e.g., when in the second or expandedconfiguration), thereby securely seating the valve 100 in the nativeannulus, as shown in FIG. 1E. In some implementations, any other oradditional portions of the valve can similarly engage native tissue tosecurely seat the valve 100 in the native annulus and/or to form a sealbetween the support frame 110 and the tissue forming the native annulus(e.g., the distal portion 122 and/or the proximal portion 124 of thesupra-annular region 120, the transannular region 112, and/or one ormore other or additional anchoring elements (not shown in FIGS. 1A-1E).

While not shown in FIGS. 1A-1E, in some implementations, the valve 100and/or the delivery system can include one or more tissue anchors thatcan be used to anchor one or more portions of the valve 100 to theannular tissue, as described in detail in the '957 PCT. In someembodiments, the tissue anchors can be configured to puncture, pierce,and/or otherwise secure the anchoring elements 132 and/or 134, and/orthe atrial collar to the annular tissue. In other embodiments, thetissue anchors can be, for example, atraumatic anchors configured tosecure the anchoring elements 132 and/or 134, and/or the atrial collarto the annular tissue without puncturing, piercing, and/or otherwisecausing trauma to the native tissue.

FIGS. 2A-2D are schematic illustrations of an annular support frame 210according to an embodiment. The annular support frame 210 (also referredto herein as “tubular frame,” “valve frame,” “wire frame,” “outerframe,” “support frame,” or “frame”) can include and/or can be coupledto an actuator 270 configured to actuate one or more portions of thesupport frame 210. In some embodiments, the support frame 210 and/or theactuator 270 can be substantially similar in at least form and/orfunction to the support frame 110 and/or the actuator 170, respectively,described above with reference to FIGS. 1A-1E. Thus, portions and/oraspects of the support frame 210 and/or the actuator 270 are notdescribed in further detail herein.

As shown, the annular support frame 210 has a supra-annular memberand/or region 220, a subannular member and/or region 230, and atransannular member and/or region 212, disposed and/or coupledtherebetween. In the embodiment shown in FIGS. 2A-2D, the supra-annularmember and/or region 220, the subannular member and/or region 230, andthe transannular member and/or region 212 are separate, independent,and/or modular components that are coupled to collectively form theframe 210. Each of the supra-annular member and/or region 220, thesubannular member and/or region 230, and the transannular member and/orregion 212 (referred to herein as the supra-annular, subannular, andtransannular “member”) are a wire frame that is laser cut out of anysuitable material such as a shape-memory or superelastic material likeNitinol. In some implementations, each of the supra-annular member 220,the subannular member 230, and the transannular member 212 can be lasercut from a sheet of Nitinol and, for example, heat-set into a desiredshape and/or configuration. As described above, forming thesupra-annular member 220, the subannular member 230, and thetransannular member 212 in such a manner can provide a desired amount offlexibility and/or resistance to plastic or permanent deformation thatcan allow the frame 210 to be folded and/or compressed for delivery.Moreover, the wire frame portions of the supra-annular member 220, thesubannular member 230, and the transannular member 212 can be covered byany suitable biocompatible material such as any of those describedabove.

In some embodiments, the supra-annular member 220 of the frame 210 canbe similar in at least form and/or function to the supra-annular member120 described above with reference to FIGS. 1A-1E. For example, thesupra-annular member 220 can be and/or can form, for example, a cuff orcollar that can be attached or coupled to an upper edge or upper portionof the transannular member 212, as described in further detail herein.In some implementations, the supra-annular member 220 can be deployed onthe atrial floor to direct blood from the atrium into a flow controlcomponent mounted to the frame 210, as described in detail above. Thesupra-annular member 220 can be shaped and/or formed to include anynumber of features configured to engage native tissue and/or one or moreother portions of the frame 210 and/or the actuator 270. For example, insome embodiments, the supra-annular member 220 can include and/or canform an outer portion or loop, an inner portion or loop, and one or moresplines disposed between the outer and inner portions or loops.

In some embodiments, the outer portion or loop (referred to herein as“outer loop”) can be shaped and/or sized to engage native tissue. Morespecifically, the supra-annular member 220 (or an outer loop thereof)can have a distal portion 222 configured to engage distal supra-annulartissue and a proximal portion 224 configured to engage proximalsupra-annular tissue. In some embodiments, the distal and proximalportions 222 and 224 can have a rounded and/or curved shape, wherein aradius of curvature of the proximal portion 224 is larger than a radiusof curvature of the distal portion 222. In some implementations, thedistal portion 222 can form, for example, a distal upper anchoringelement that can engage distal supra-annular tissue to at leastpartially stabilize and/or secure the frame 210 in the native annulus.Similarly, the proximal portion 224 can form, for example, a proximalupper anchoring element that can engage proximal supra-annular tissue toat least partially stabilize and/or secure the frame 210 in the nativeannulus.

The inner portion or loop (referred to herein as “inner loop”) of thesupra-annular member 220 can be substantially circular and can becoupled to and/or suspended from the outer loop by the one or moresplines. As described in further detail herein with reference tospecific embodiments, the inner loop can be coupled to an inner frame ofthe flow control component to at least partially mount the flow controlcomponent to the support frame 210. In some implementations, suspendingthe inner loop from the outer loop (via the one or more splines) can,for example, at least partially isolate the inner loop from at least aportion of the force associated with transitioning the frame 210 betweenthe expanded configuration and the compressed configuration, asdescribed in further detail herein. Moreover, mounting the flow controlcomponent to the inner loop of the supra-annular member 220 similarly atleast partially isolates and/or reduces an amount of force transferredto the flow control component when the frame 210 is transitioned betweenits expanded configuration and its compressed configuration.

The one or more splines of the supra-annular member 220 can be anysuitable shape, size, and/or configuration. For example, in someembodiments, the supra-annular member 220 can include a distal splineand a proximal spline. As described above, the splines can be configuredto support the inner loop and/or otherwise couple the inner loop to theouter loop. In some embodiments, the supra-annular member 220 caninclude a spline (e.g., a proximal spline) configured to receive, coupleto, and/or otherwise engage the actuator 270 and/or delivery systeminterface. For example, in some embodiments, a proximal spline can forma connection point, attachment point, waypoint, and/or any othersuitable feature that can temporarily and/or removably couple to theactuator 270, as described in further detail herein with reference tospecific embodiments.

In some embodiments, the subannular member 230 of the frame 210 can besimilar in at least form and/or function to the subannular region 130described above with reference to FIGS. 1A-1E. For example, thesubannular member 230 of the frame 210 can be and/or can form, forexample, a cuff or collar that can be attached or coupled to a loweredge or upper portion of the transannular member 212, as described infurther detail herein. When the frame 210 is deployed within a humanheart, the subannular member 230 can be a ventricular collar that isshaped to conform to the native deployment location. In a tricuspidand/or mitral valve replacement, for example, the subannular member 230or collar can have various portions configured to conform to the nativevalve and/or a portion of the ventricular ceiling surrounding thetricuspid and/or mitral valve, respectively. In some implementations,the subannular member 230 or at least a portion thereof can engage theventricular ceiling surrounding the native annulus to secure the frame210 in the native annulus, to prevent dislodging of the frame 210, tosandwich or compress the native annulus or adjacent tissue between thesupra-annular member 220 and the subannular member 230, and/or to sealagainst blood leakage (perivalvular leakage and/or regurgitation duringsystole) around the frame 210.

The subannular member 230 can be shaped and/or formed to include anynumber of features configured to engage native tissue, one or more otherportions of the frame 210, and/or the actuator 270. For example, in someembodiments, the subannular member 230 can include and/or can form adistal portion having a distal anchoring element 232 and a proximalportion having a proximal anchoring element 234. In some embodiments,the subannular member 230 can include and/or can form any other suitableanchoring element (not shown in FIGS. 2A-2D). In some embodiments, theanchoring elements 232 and 234 are integrally and/or monolithicallyformed with the subannular member 230. The distal anchoring element 232and the proximal anchoring element 234 of the subannular member 230 canbe any suitable shape, size, and/or configuration such as any of thosedescribed in detail in the '957 PCT, the '010 PCT, the '231 PCT, the'390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the'345 Provisional, the '807 Provisional, any of those described abovewith reference to the valve 100, and/or any of those described hereinwith respect to specific embodiments.

In some embodiments, the distal anchoring element 232 can optionallyinclude a guidewire coupler configured to selectively engage and/orreceive a portion of a guidewire or a portion of a guidewire assembly.The guidewire coupler is configured to allow a portion of the guidewireto extend through an aperture of the guidewire coupler, thereby allowingthe frame 210 to be advanced over or along the guidewire during deliveryand deployment. In some embodiments, the guidewire coupler canselectively allow the guidewire to be advanced therethrough whileblocking or preventing other elements and/or components such as a pusheror the like.

The anchoring elements 232 and/or 234 of the subannular member 230 canbe configured to engage a desired portion of the native tissue to mountthe frame 210 to the annulus of the native valve in which it isdeployed. For example, in some implementations, the distal anchoringelement 232 can be a projection or protrusion extending from thesubannular member 230 and into a RVOT or a LVOT. In suchimplementations, the distal anchoring element 232 can be shaped and/orbiased such that the distal anchoring element 232 exerts a force on thesubannular tissue operable to at least partially secure the distal endportion of the frame 210 in the native annulus. In some implementations,the proximal anchoring element 234 can be configured to engagesubannular tissue on a proximal side of the native annulus to aid in thesecurement of the frame 210 in the annulus.

In some implementations, at least the proximal anchoring element 234 canbe configured to transition, move, and/or otherwise reconfigure betweena first configuration in which the proximal anchoring element 234extends from the subannular member 230 a first amount or distance and asecond configuration in which the proximal anchoring element 234 extendsfrom the subannular member 230 a second amount or distance. As describedabove, the subannular member 230 of the frame 210 can be and/or caninclude, for example, a laser cut wire frame formed of a shape-memorymaterial such as Nitinol, which is heat-set into a desired shape. Insome embodiments, heat-setting the subannular member 230 can includeforming one or more twists in a portion of the laser cut wire, which inturn, can allow one or more portions of the subannular member 230 to bebiased in different directions and/or orientations. For example, ingeneral, the subannular member 230 of the frame 210 can be formed toprovide a high amount of flexibility in a direction that allows thesubannular member 230 to be folded and/or compressed (e.g., relative toa longitudinal axis of the subannular member 230). In some embodiments,however, a portion of the subannular member 230 can be twisted and/orotherwise oriented to provide a high amount of flexibility in adirection that allows the proximal anchoring element 234 to be actuatedand/or to otherwise transition between its first and secondconfigurations (e.g., in a direction orthogonal to the longitudinal axisof the subannular member 230 and orthogonal to a fold and/or compressiondirection.

In some embodiments, the proximal anchoring element 234 can be in acompressed, contracted, retracted, undeployed, folded, and/or restrainedstate (e.g., a position that is near, adjacent to, and/or in contactwith the transannular member 212 and/or the supra-annular member 220 ofthe support frame 210) when in the first configuration, and can be in anexpanded, extended, deployed, unfolded, and/or unrestrained state (e.g.,extending away from the transannular member 212) when in the secondstate. In some embodiments, the proximal anchoring element 234 can bebiased and/or heat-set in the second configuration. Moreover, in someimplementations, the proximal anchoring element 234 can be transitionedin response to actuation of the actuator 270, as described in furtherdetail herein.

In some implementations, the proximal anchoring element 234 can betransitioned from the first configuration to the second configurationduring deployment to selectively engage native tissue, chordae,trabeculae, annular tissue, leaflet tissue, and/or any other anatomicstructures to aid in the securement of the frame 210 in the nativeannulus. The proximal anchoring element 234 (and/or the distal anchoringelement 232) can include any suitable feature, surface, member, etc.configured to facilitate the engagement between the proximal anchoringelement 234 (and/or the distal anchoring element 232) and the nativetissue. For example, in some embodiments, the proximal anchoring element234 can include one or more features configured to engage and/or becomeentangled in the native tissue, chordae, trabeculae, annular tissue,leaflet tissue, and/or any other anatomic structures when in the secondconfiguration, as described in further detail herein with reference tospecific embodiments.

In some embodiments, the transannular member 212 of the frame 210 can besimilar in at least form and/or function to the transannular region 112described above with reference to FIGS. 1A-1E. For example, thetransannular member 212 is disposed between the supra-annular member 220and the subannular member 230. In some embodiments, the transannularmember 212 can be coupled to each of the supra-annular member 220 andthe subannular member 230 such that a desired amount of movement and/orflex is allowed therebetween (e.g., welded, bonded, sewn, bound, and/orthe like). For example, in some implementations, the transannular member212 and/or portions thereof can be sewn to each of the supra-annularmember 220 and the subannular member 230 (and/or portions thereof). Thetransannular member 212 can be shaped and/or formed into a ring, acylindrical tube, a conical tube, D-shaped tube, and/or any othersuitable annular shape, as described above with reference to thetransannular member 112. In some embodiments, the transannular member212 can have a shape and/or size that is at least partially based on asize, shape, and/or configuration of the supra-annular member 220 and/orsubannular member 230 of the support frame 210, the flow controlcomponent configured to be coupled to the support frame 210, and/or thenative annulus in which it is configured to be deployed. For example,the transannular member 212 can have an outer circumference surface forengaging native annular tissue that may be tensioned against an inneraspect of the native annulus to provide structural patency to a weakenednative annular ring.

As described above, the supra-annular member 220, the subannular member230, and the transannular member 212 can be independent and/or modularcomponents that are coupled to collectively form the frame 210. In someembodiments, the supra-annular member 220 is configured to engagesupra-annular tissue of the native valve and can be shaped and/or biasedto form a substantially fluid tight seal with the atrial floor to limitand/or substantially prevent leakage around the frame (e.g.,perivalvular leaks). Similarly, the subannular member 220 is configuredto engage subannular tissue of the native valve and can be shaped and/orbiased to form a substantially fluid tight seal with the ventricularceiling to limit and/or substantially prevent leakage around the frame.Moreover, in some implementations, the transannular member 212 can havea slightly oversized circumference relative to the native annular tissueand can, for example, form at least a partial seal between thetransannular member 212 of the frame 210 and the native tissue formingthe walls of the annulus. In such implementations, forming a sealagainst the atrial floor, the ventricular ceiling, and the walls of theannulus can provide redundancy in the event of an imperfect or partialseal formed by one or more of the supra-annular member(s) 220, thesubannular member 230, and/or the transannular member 212.

In other implementations, the distal and proximal anchoring elements 232and 234 can exert a force on the subannular tissue that is operable inpulling the supra-annular member 220 of the frame 210 toward the atrialfloor, thereby facilitating the formation of a seal. In suchimplementations, for example, the subannular member 230 and/or thetransannular member 212 need not form a seal or can form a partiallyseal with the native tissue because of the seal formed by thesupra-annular member 220.

In some implementations, the arrangement of the frame 210 can be suchthat structural support and/or stiffness is provided by thesupra-annular member 220 and the subannular member 230, while thetransannular member 212 need not provide substantial support and/orstiffness. In some such implementations, the transannular member 212 canbe configured to couple the supra-annular member 220 to the subannularmember 230 and to easily deform (elastically) for delivery rather thanprovide substantial support and/or stiffness. Moreover, while thetransannular member 212 is described above as being formed by a lasercut wire frame that is covered by biocompatible material, in otherembodiments, the transannular member 212 can be formed from any suitableflexible material such as pericardial tissue, fabric, polyester, and/orthe like. In some such embodiments, forming the flexible materialwithout the laser cut wire frame can, for example, reduce a size of theframe 210 when in the compressed configuration, thereby allowing a valveto be delivered using a smaller delivery catheter. In some embodiments,the frame 210 need not include a separate transannular member 212. Forexample, in such embodiments, a flow control component can be coupledbetween the supra-annular member 220 and the subannular member 230,thereby allowing a further reduction in a size of a valve in thecompressed configuration.

As shown in FIGS. 2A-2D, the actuator 270 can be at least temporarilycoupled to the supra-annular member 220 and the subannular member 230.In some embodiments, the actuator 270 or a portion thereof can also atleast temporarily couple to a portion of the transannular member 212.The actuator 270 can be any suitable member, mechanism, and/or deviceconfigured to actuate at least a portion of the frame 210. Moreover, aportion of the actuator 270 can extend through a portion of a deliverysystem used to deliver the frame 210 and/or a valve including the frame210. In this manner, a user can manipulate a proximal end portion of theactuator 270 to actuate the actuator 270.

In some embodiments, the actuator 270 and/or a portion of the actuator270 can be configured to at least temporarily couple to the spline ofthe supra-annular member 220 (e.g., an attachment point, waypoint,connector, threaded coupler, etc.) and can be configured to actuate oneor more portions of the frame 210. The actuator 270 can be configured toactuate at least the proximal anchoring element 234 of the subannularmember 220 of the support frame 210 to transition the proximal anchoringelement 234 between its first and second configurations (describedabove).

In some implementations, the actuator 270 can include one or morecables, tethers, linkages, joints, connections etc., that can exert aforce (or can remove an exerted force) on a portion of the proximalanchoring element 234 operable to transition the proximal anchoringelement 234 between the first and second configuration. For example, theactuator 270 can couple to a waypoint or the like of the supra-annularmember 220 and can include one or more tethers, cables, and/or membersthat extend through the waypoint and/or one or more openings orapertures and couple to the proximal anchoring element 234. In someimplementations, the one or more tethers, cables, and/or members can beremovably and/or temporarily coupled to the proximal anchoring element234, as described, for example, in the '010 PCT, the '108 PCT, and/orthe '345 Provisional.

As described above, the subannular member 230 can be formed with theproximal anchoring element 234 biased in the uncompressed and/orexpanded configuration. In this manner, the actuator 270 can be actuatedto exert a force, via the one or more cables, tethers, etc., operable totransition the proximal anchoring element 234 to the compressed and/orretracted configuration. More specifically, the user can manipulate theproximal end portion of the actuator 270 to actuate a distal end portionof the actuator 270 that is coupled to the frame 210. For example,actuating the actuator 270 can be such that the one or more cables,tethers, and/or members are pulled in a proximal direction (e.g., awayfrom the frame 210 and/or in a manner that increases a tension therein),as indicated by the arrow AA in FIG. 2B. The coupling of the distal endportion of the actuator 270 to the frame 210 can be such that theproximal movement of the cables, tethers, etc., pull the proximalanchoring element 234 toward a central axis of the frame 210, asindicated by the arrow BB in FIG. 2B. As such, actuating the actuator270 can exert a force on the proximal anchoring element 234 operable toplace the proximal anchoring element 234 in a compressed, retracted,restrained, and/or actuated configuration, as shown in FIG. 2B.

In some implementations, actuating the actuator 270 also can be operableto pull a proximal-anterior portion of the subannular member and/ortransannular wall and a proximal-posterior portion of the subannularmember and/or transannular wall to or toward the longitudinal axis ofthe valve 200. For example, FIG. 2C shows that the actuation of theactuator 270 (e.g., moving the actuator 270 or tethers in the AAdirection) compresses and/or moves the proximal anchoring element 234toward a central portion of the valve frame 210, as indicated by thearrow BB, and compresses the posterior and anterior sidewalls toward acentral portion of the valve frame 210, as indicated by the arrows CC.As such, actuating the actuator 270 can reduce a perimeter of at leastthe subannular member 230 allowing a desired portion of the valve frame210 to be inserted into the annulus of the native valve.

In some implementations, the actuator 270 can be secured and/or lockedwhen the proximal anchoring element 234 is compressed and/or retracted(e.g., a first configuration) to at least temporarily maintain theproximal anchoring element 234 in the first configuration. As describedabove, in some implementations, the proximal anchoring element 234 canbe in the first configuration for delivery and deployment prior toseating the frame 210 (or valve) in the native annulus. Once the frame210 is seated in the native annulus, a user can manipulate the proximalportion of the actuator 270 to actuate and/or release the actuator 270.In this example, the actuation can cause the actuator 270 to releaseand/or remove at least a portion of the force exerted on the proximalanchoring element 234 (e.g., via the cable(s), tether(s), etc.), therebyallowing the proximal anchoring element 234 (and/or one or more portionsof the anterior and/or posterior walls) to return to its biasedconfiguration or a second configuration (see e.g., FIG. 2A), asdescribed above.

In some implementations, the actuator 270 can be configured to furtheractuate the frame 210 after the frame 210 (or valve) is seated in thenative annulus. For example, in some implementations, the user canmanipulate the proximal end portion of the actuator 270 (e.g., in thesame way as just described or in a different manner) to move one or morecables, tethers, and/or members of the actuator 270 in the proximaldirection (e.g., away from the frame 210 and/or in a manner thatincreases a tension therein), as indicated by the arrow DD in FIG. 2D.In this example, the proximal anchoring element 234 is in itsuncompressed or unactuated state after seating the frame 210 in thenative annulus. The actuator 270 can be coupled to the supra-annularmember 220, the subannular member 230, and/or the proximal anchoringelement 234 such that the actuation of the actuator 270 results in aforce operable to pull the proximal anchoring element 234 toward theproximal portion 224 of the supra-annular member 220, as indicated bythe arrow EE in FIG. 2D. For example, the actuator 270 can exert acompressive force or the like that is operable in cinching at leastportion of the frame 210.

As shown in FIG. 2D, in some instances, the proximal anchoring element234 can flex in the direction of the native annulus (e.g., beyond itsbiased position), which can facilitate an engagement between theproximal anchoring element 234 and the native tissue and/or chordae onthe proximal side of the native annulus. In some implementations, theforce resulting from the actuation of the actuator 270 can be operableto pull, move, compress, and/or cinch other portions of the subannularmember 230 toward the supra-annular member 220, as indicated by thearrow FF in FIG. 2D. In some such implementations, an amount of cinchingcan be varied across the frame 210. For example, an amount of cinchingat or near a proximal portion of the frame 210 can be greater than anamount of cinching at or near a distal portion of the frame 210. Inother implementations, the amount of cinching can be substantiallyconsistent across the frame 210. Moreover, at least some tissuesurrounding the native annulus can be disposed between the supra-annularmember 220 and the subannular member 230 when the frame 210 is seated inthe native annulus and thus, the cinching of the supra-annular member220 and the subannular member 230 can be operable to squeeze and/orsandwich the native tissue between the members 220 and 230. In thismanner, the cinching can enhance a securement of the frame 210 in thenative annulus.

Although not shown in FIGS. 2A-2D, in some embodiments, the proximalanchoring element 234 can be sized and/or shaped to engage nativetissue, chordae, trabeculae, annular tissue, leaflet tissue, and/or thelike when the frame 210 is cinched against or relative to the nativeannulus. In some embodiments, the proximal anchoring element 234 caninclude one or more protrusions, features, ridges, ribs, knobs, knots,beads, loops, etc. that can engage and/or that can facilitate theengagement of the native tissue when the frame 210 is cinched against orrelative to the native annulus.

While the frame 210 and/or one or more portions of the subannular member230 are described above as being compressed to move inward toward acentral axis of the frame 210 in response to actuation of the actuator270, in other embodiments, the actuator 270 can be removably coupled toone or more portions of the frame 210 and configured to move suchportions in any suitable manner. For example, in some implementations,the actuator 270 (e.g., one or more tethers or the like, as describedabove) can be coupled to the proximal anchoring element 234 such thatactuation of the actuator 270 results in the proximal anchoring element234 folding or wrapping around the transannular member 212 of the frame210 in either an anterior direction or a posterior direction, or bothdirections depending on the mode of actuation. As described above, thefolding and/or wrapping of the proximal anchoring element 234 around thetransannular member 212 can reduce a circumference or diameter of atleast the subannular member 230 allowing the frame 210 to be insertedinto and/or at least partially through the annulus of the native heartvalve.

FIGS. 3A-3C are schematic illustrations of an annular support frame 310according to an embodiment. The annular support frame 310 (also referredto herein as “tubular frame,” “valve frame,” “wire frame,” “outerframe,” “support frame,” or “frame”) can include and/or can be coupledto an actuator 370 configured to actuate one or more portions of thesupport frame 310. In some embodiments, the support frame 310 and/or theactuator 370 can be substantially similar in at least form and/orfunction to the support frames 110, 210 and/or the actuators 170, 270,respectively. Thus, portions and/or aspects of the support frame 310and/or the actuator 370 are not described in further detail herein.

As shown, the annular support frame 310 has a supra-annular memberand/or region 320, a subannular member and/or region 330, and atransannular member and/or region 312, disposed and/or coupledtherebetween. In the embodiment shown in FIGS. 3A-3C, the supra-annularmember and/or region 320, the subannular member and/or region 330, andthe transannular member and/or region 312 are separate, independent,and/or modular components that are coupled to collectively form theframe 310. Each of the supra-annular member and/or region 320, thesubannular member and/or region 330, and the transannular member and/orregion 312 (referred to herein as the supra-annular, subannular, andtransannular “member”) are a wire frame that is laser cut out of anysuitable material such as a shape-memory or superelastic material likeNitinol. In some implementations, each of the supra-annular member 320,the subannular member 330, and the transannular member 312 can be lasercut from a sheet of Nitinol and, for example, heat-set into a desiredshape and/or configuration. As described above, forming thesupra-annular member 320, the subannular member 330, and thetransannular member 312 in such a manner can provide a desired amount offlexibility and/or resistance to plastic or permanent deformation thatcan allow the frame 310 to be folded and/or compressed for delivery.Moreover, the wire frame portions of the supra-annular member 320, thesubannular member 330, and the transannular member 312 can be covered byany suitable biocompatible material such as any of those describedabove.

In some embodiments, the supra-annular member 320 of the frame 310 canbe similar in at least form and/or function to the supra-annular members120, 220 described above. For example, the supra-annular member 320 canbe and/or can form, for example, a cuff or collar that can be attachedor coupled to an upper edge or upper portion of the transannular member312. The supra-annular member 320 can be shaped and/or formed to includeany number of features configured to engage native tissue and/or one ormore other portions of the frame 310 and/or the actuator 370. Forexample, the supra-annular member 320 (or an outer loop thereof) canhave a distal portion 322 configured to engage distal supra-annulartissue and a proximal portion 324 configured to engage proximalsupra-annular tissue.

As described above, the supra-annular member 320 can include and/or canform an outer portion or loop, an inner portion or loop, and one or moresplines disposed between the outer and inner portions or loops. Theouter portion or loop (referred to herein as “outer loop”) can be shapedand/or sized to engage native tissue. In some implementations, the outerloop can form, for example, one or more upper or supra-annular anchoringelements that can engage supra-annular tissue to at least partiallystabilize and/or secure the frame 310 in the native annulus. The innerportion or loop (referred to herein as “inner loop”) of thesupra-annular member 320 is coupled to and/or suspended from the outerloop by the one or more splines and is coupleable to an inner frame ofthe flow control component to at least partially mount the flow controlcomponent to the support frame 310, as described above with reference tothe supra-annular member 220. The one or more splines of thesupra-annular member 320 can be any suitable shape, size, and/orconfiguration. For example, in some embodiments, the supra-annularmember 320 can include a distal spline and a proximal spline. In someembodiments, the supra-annular member 320 can include a spline (e.g., aproximal spline) configured to receive, couple to, and/or otherwiseengage the actuator 370 and/or delivery system interface. For example,in the embodiment shown in FIGS. 3A-3C, the supra-annular member 330(e.g., a spline thereof) can form a waypoint and/or the like that cantemporarily and/or removably couple to and/or receive the actuator 370and any other suitable portion of the delivery system, as described infurther detail herein with reference to specific embodiments.

The subannular member 330 of the frame 310 can be similar in at leastform and/or function to the subannular regions and/or members 130, 230described above. For example, the subannular member 330 of the frame 310can be and/or can form, for example, a cuff or collar that can beattached or coupled to a lower edge or upper portion of the transannularmember 312. When the frame 310 is deployed within a human heart, thesubannular member 330 can be a ventricular collar that is shaped toconform to the native deployment location. In some implementations, thesubannular member 330 or at least a portion thereof can engage theventricular ceiling surrounding the native annulus to secure the frame310 in the native annulus, to prevent dislodging of the frame 310 and/orto seal against blood leakage (perivalvular leakage and/or regurgitationduring systole) around the frame 310.

The subannular member 330 included in the frame 310 shown in FIGS. 3A-3Ccan include and/or can form a distal portion having a distal anchoringelement 332 and a proximal portion having a proximal anchoring element334. In some embodiments, the subannular member 330 can include and/orcan form any other suitable anchoring element (not shown in FIGS.3A-3C). The anchoring elements 332 and 334 can be integrally and/ormonolithically formed with the subannular member 330. The distalanchoring element 332 and the proximal anchoring element 334 of thesubannular member 330 can be any suitable shape, size, and/orconfiguration such as any of those described in detail in the '957 PCT,the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327Provisional, the '964 Provisional, the '345 Provisional, the '807Provisional, any of those described above with reference to the valve100, and/or any of those described herein with respect to specificembodiments. The distal anchoring element 332 can be substantiallysimilar to the distal anchoring elements 132, 232 and therefore, is notdescribed in further detail herein.

The proximal anchoring element 334 can be configured to transition,move, and/or otherwise reconfigure between a first configuration inwhich the proximal anchoring element 334 extends from the subannularmember 330 a first amount, distance, and/or direction and a secondconfiguration in which the proximal anchoring element 334 extends fromthe subannular member 330 a second amount, distance, and/or direction.In some embodiments, the proximal anchoring element 334 can besubstantially similar in at least form and/or function to the proximalanchoring element 234 described above with reference to FIGS. 2A-2D.Accordingly, such similarities are not described in further detailherein.

In some embodiments, the proximal anchoring element 334 can be in acompressed, contracted, retracted, undeployed, folded, and/or restrainedstate (e.g., a position that is near, adjacent to, and/or in contactwith the transannular member 312 and/or the supra-annular member 320 ofthe support frame 310) when in the first configuration, and can be in anexpanded, extended, deployed, unfolded, and/or unrestrained state (e.g.,extending away from the transannular member 312) when in the secondstate. In some embodiments, the proximal anchoring element 334 can bebiased and/or heat-set in the second configuration. Moreover, in someimplementations, the proximal anchoring element 334 can be transitionedin response to actuation of the actuator 370, as described in furtherdetail herein.

The transannular member 312 is disposed between the supra-annular member320 and the sub annular member 330. In some embodiments, thetransannular member 312 can be coupled to each of the supra-annularmember 320 and the subannular member 330 such that a desired amount ofmovement and/or flex is allowed therebetween (e.g., welded, bonded,sewn, bound, and/or the like). In some embodiments, the transannularmember 312 of the frame 310 can be similar in at least form and/orfunction to the transannular regions 112, 212 described above and thus,is not described in further detail herein.

While the frame 310 is described above as being substantially similar tothe frame 210 described above with reference to FIGS. 2A-2D, the frame310 can differ from the frame 210 in the engagement with the actuatorand the movement of the proximal anchoring element 334. As shown inFIGS. 3A-3C, the actuator 370 can at least temporarily engage with thesupra-annular member 320 and the subannular member 330. The actuator 370can be any suitable member, mechanism, and/or device configured toactuate at least a portion of the frame 310. Moreover, a portion of theactuator 370 can extend through a portion of a delivery system used todeliver the frame 310 and/or a valve including the frame 310. In thismanner, a user can manipulate a proximal end portion of the actuator 370to actuate the actuator 370.

FIG. 3A shows the actuator 370 engaged with the frame 310 while theframe 310 is in a compressed or delivery configuration. As describedabove with reference to the valve 100, the frame 310 can be compressed,folded, and/or otherwise placed into a delivery configuration forside-delivery via a delivery catheter. Prior to placing the frame 310 inthe delivery system, the actuator 370 can be removably coupled to theframe 310 such that the frame 310 (or valve) and the actuator 370 areadvanced through the delivery catheter together. In this embodiment, theactuator 370 can be a tether that extends through the waypoint 328defined by the supra-annular member 320, looped through one or moreattachment points of the subannular member 330 (e.g., one or moreattachment points on or near the proximal anchoring element 334, andthen looped back through the waypoint 328. As such, both ends of thetether are proximal to the frame 310 and can be maintained proximal toand/or at a proximal end of the delivery system, allowing an operator tomanipulate the actuator 370 (tether) to actuate the proximal anchoringelement 334. FIG. 3A shows that the proximal anchoring element 334 is inan extended or unactuated configuration when the frame 310 is in thedelivery configuration for side-delivery through the delivery catheter.

FIG. 3B shows the actuator 370 being actuated to move the proximalanchoring element 334 from the first position or configuration to thesecond position or configuration. More specifically, the frame 310(and/or valve) can advanced through the delivery catheter and allowed toat least partially expand as the frame 310 is released from the deliverycatheter. In some implementations, the frame 310 is at least partiallyinserted into the annulus while the proximal end portion of the frame310 remains in the delivery catheter. After fully releasing the frame310 from the delivery catheter, the operator can manipulate the proximalend portion of the actuator 370 to actuate a distal end portion of theactuator 370 that is coupled to the proximal anchoring element 334.

For example, actuating the actuator 370 can be such that the one or moretethers are pulled in a proximal direction (e.g., away from the frame310 and/or in a manner that increases a tension therein), as indicatedby the arrow GG in FIG. 3B. With the actuator 370 passing through thewaypoint 328 of the supra-annular member 320, which in this embodimentis not actuated by the actuator 370), the proximal movement of thecables, tethers, etc., pull the proximal anchoring element 334 towardthe waypoint 328, as indicated by the arrow HH in FIG. 3B. As such,actuating the actuator 370 can exert a force on the proximal anchoringelement 334 operable to place the proximal anchoring element 334 in acompressed, retracted, restrained, and/or actuated configuration, asshown in FIG. 3B. As described above, placing the proximal anchoringelement 334 in the compressed and/or actuated configuration reduces aperimeter of at least the subannular member 330 allowing the subannularmember 330 to be passed through the annulus of the native valve.

After the frame 310 (or valve) is seated in the annulus, the actuator370 can be actuated again and/or otherwise returned to an unactuatedstate or configuration. As such, the proximal anchoring element 334 isallowed to return to the extended and/or unactuated configuration. Inthe embodiment shown in FIGS. 3A-3C, the proximal anchoring element 334can be biased such that in the extended and/or unactuated configuration,the proximal anchoring element 334 engages native subannular tissue toat least partially secure the frame 310 in the annulus. FIG. 3C showsthat once the frame 310 is seated in the annulus, the operator canmanipulate the actuator 370 to remove the actuator 370 from the frame310. For example, the operator can pull on one end of the tether (e.g.,actuator 370) such that the tether is withdrawn from the attachmentpoints of the subannular member 330 and the waypoint 328 of thesupra-annular member 320. As such, the actuator 370 and/or a deliverysystem of which the actuator 370 is a part can be withdrawn from apatient while the frame 310 remains in the annulus of the native heartvalve.

Provided below is a discussion of certain aspects or embodiments of sidedeliverable transcatheter prosthetic valves (e.g., prosthetic valves).The transcatheter prosthetic valves (or aspects or portions thereof)described below with respect to specific embodiments can besubstantially similar in at least form and/or function to the valves 100and/or 200 (or corresponding aspects or portions thereof). Similarly,the valves described below (or aspects or portions thereof) can besimilar in at least form and/or function to the valves described indetail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the'108 PCT, the '327 Provisional, the '964 Provisional, the '345Provisional, and/or the '807 Provisional. Thus, certain aspects and/orportions of the specific embodiments may not be described in furtherdetail herein.

FIGS. 4-10 illustrate a side-deliverable (orthogonally deliverable)transcatheter prosthetic heart valve 400 (also referred to herein as“prosthetic valve” or “valve”), according to an embodiment. FIG. 4 is anillustration of a top perspective view of the valve 400. In someimplementations, the valve 400 can be deployed in, for example, anannulus of a native tricuspid and/or mitral valve. The valve 400 isconfigured to permit blood flow in a first direction through an inflowend of the valve 400 and to block blood flow in a second direction,opposite the first direction, through an outflow end of the valve 400.For example, the prosthetic valve 400 can be a side deliverabletranscatheter prosthetic heart valve configured to be deployed withinthe annulus of a native tricuspid valve or native mitral valve of ahuman heart to supplement and/or replace the functioning of the nativevalve.

The valve 400 is compressible and expandable in at least one directionrelative to an x-axis of the valve 400 (also referred to herein as“horizontal axis,” “longitudinal axis,” “long axis,” and/or “lengthwiseaxis”). The valve 400 is compressible and expandable between an expandedconfiguration for implanting at a desired location in a body (e.g., ahuman heart) and a compressed configuration for introduction into thebody using a delivery catheter (not shown in FIG. 4). In someembodiments, the horizontal x-axis of the valve 400 is orthogonal to (90degrees), or substantially orthogonal to (75-105 degrees), orsubstantially oblique to (45-135 degrees) to a central (vertical) y-axiswhen in the expanded and/or compressed configuration. Moreover, thehorizontal x-axis of the valve 400 in the compressed configuration issubstantially parallel to a lengthwise cylindrical axis of the deliverycatheter in which the valve 400 is disposed.

In some embodiments, the valve 400 has an expanded or deployed height ofabout 5-60 mm, about 5-30 mm, about 5-20 mm, about 8-12 mm, or about8-10 mm, and an expanded or deployed diameter (e.g., length and/orwidth) of about 25-80 mm, or about 40-80 mm. In some embodiments, thevalve 400 has a compressed height (y-axis) and width (z-axis) of about6-15 mm, about 8-12 mm, or about 9-10 mm. It is contemplated in someimplementations that the length of the valve 400 (e.g., along thex-axis) is not compressed or otherwise reduced since it can extend alongthe length of the central cylindrical axis of the delivery catheter.

In certain embodiments, the valve 400 is centric, or radiallysymmetrical. In other embodiments, the valve 400 is eccentric, orradially asymmetrical (e.g., along or relative to the y-axis). In someeccentric embodiments, the frame 410 may have a D-shape incross-section, with a flat portion or surface configured tosubstantially match an annulus of a native mitral valve at or near theanterior leaflet. In the example shown in FIGS. 4-10, the valve 400 iseccentric with one or more components being offset or asymmetricalregion to the y-axis.

The valve 400 includes an annular outer support frame 410 and acollapsible flow control component 450 mounted within the annular outersupport frame 410. The annular outer support frame 410 (also referred toherein as “outer frame”) is made from a shape-memory material such asNickel-Titanium alloy (Nitinol) and is therefore a self-expandingstructure from a compressed configuration to an expanded configuration.As shown in FIG. 4, at least the outer support frame 410 of the valve400 is covered, wrapped, and/or surrounded by a biocompatible cover 440.The biocompatible cover 440 can be a mesh material, a pericardialtissue, a woven synthetic polyester material, and/or any other suitablebiocompatible material such as those described above.

The outer frame 410 has a transannular member 412 and/or body thatcircumscribes, forms, and/or defines a central (interior) channel aboutand/or along the vertical or central axis (y-axis). The outer frame 410has a supra-annular member 420 attached circumferentially at a top edgeof the transannular member 412 and a subannular member 410 attachedcircumferentially at a bottom edge of the transannular member 412. Thesupra-annular member 420 is shaped to conform to the native deploymentlocation. In a tricuspid replacement, for example, the supra-annularmember 420 or atrial collar can have a tall back wall portion to conformto the septal area of the native valve and can have a distal andproximal portion. The distal portion can be larger than the proximalportion to account for the larger flat space above (atrial) theventricular outflow tract (VOT) subannular area. In a mitralreplacement, for example, the supra-annular member 420 of the outerframe 410 may be D-shaped or shaped like a hyperbolic paraboloid tomimic the native structure.

The collapsible (inner) flow control component 450 is mounted within theouter frame 410. The flow control component 450 has a foldable andcompressible inner wire frame 35 (also referred to as “inner leafletframe” or “inner frame”) with two (or more) fold areas, hinge areas,coupling areas, elastically deformable regions, etc. A set of 2-4flexible leaflets 456 are mounted in or on the inner frame 451 (notshown in FIG. 4). In some embodiments, the flow control component 450has three leaflets 456 cusps or pockets mounted within the inner frame451, as described in further detail herein.

The inner flow control component 450, like the outer frame 410, isfoldable and compressible. For example, the inner frame 451 is foldablealong or in the direction of a z-axis (e.g., foldable at the fold areasor the like) from a cylindrical configuration to a flattened cylinderconfiguration (or a two-layer band), where the fold areas are located ona distal side and on a proximal side of the inner frame 451. The flowcontrol component 450, like the outer frame 410, is also vertically(y-axis) compressible to a shortened or compressed configuration. Byfolding (compressing) in the direction of the z-axis and verticallycompressing in the y-axis, the valve 400 is permitted to maintain arelatively large dimension along the horizontal (x-axis). In someimplementations, the outer frame 410 and the flow control component 450are reduced along z-axis until the side walls are in contact or nearlyso. This also allows the outer frame 410 and the flow control component450 to maintain the radius along the horizontal axis (x-axis), tominimize the number of wire cells, which make up the outer and the innerframes, that can be damaged by forces applied during folding and/orcompression necessary for loading into the delivery catheter.

The flow control component 450 has a diameter and/or perimeter that issmaller than a diameter and/or perimeter of the central channel of theouter frame 410. The flow control component 450 is mounted to or withinthe outer frame 410 such that a central or vertical axis (y-axis) of theinner frame 451 is parallel to the central or vertical axis (y-axis) ofthe outer frame 410. In some embodiments, the y-axis defined by theinner frame 451 is parallel to but offset from the y-axis defined by theouter frame 410 (FIG. 4). In some implementations, a spacer element 445is disposed within and/or across the central channel and can facilitatethe mounting of a portion of the flow control component 450 (e.g., anotherwise unsupported portion) to the outer support frame 410 and/or aningrowth of native tissue over at least a portion of the supra-annularmember 420 of the valve 400, in some embodiments, the spacer element 445can be similar to any of those described in the '231 PCT.

In certain embodiments, the inner frame 451 can have a diameter of about25-30 mm, the outer frame 410 (or the transannular member 412 thereof)can have a diameter of about 50-80 mm, and the supra-annular member 420(or atrial collar) extend beyond the top edge of the transannular member412 by about 20-30 mm to provide a seal on the atrial floor againstperivalvular leaks (PVLs). The flow control component 450 and the outerframe 410 can be foldable (e.g., in the direction of the z-axis) and/orcompressible (e.g., in the direction of the y-axis) to reduce a size ofthe entire valve 400 to fit within the inner diameter of a 24-36 Fr(8-12 mm inner diameter) delivery catheter (not shown in this FIG. 4).

FIG. 5 is a top perspective view illustrating the supra-annular member420 of the outer support frame 410 of the valve 400 shown in FIG. 4.FIG. 5 shows a laser cut wire frame of the supra-annular member 420 witha biocompatible material 426 coupled thereto to facilitate the mountingof the inner flow control component 450 to the outer frame 410. In someembodiments, the supra-annular member 420 of the outer frame 410 can besubstantially similar in at least form and/or function to thesupra-annular members 120 and/or 220 described above. Thus, portionsand/or aspects of the supra-annular member 420 may not be described infurther detail herein.

As shown, the supra-annular member 420 includes a distal portion 422, aproximal portion 424, an outer loop 421, an inner loop 425, and at leastone spline 427. In some embodiments, the outer loop 421 can be shapedand/or sized to engage native tissue. For example, the distal portion422 of the supra-annular member 420 (formed at least in part by theouter loop 421) is configured to engage distal supra-annular tissue andthe proximal portion 424 (formed at least in part by the outer loop 421)is configured to engage proximal supra-annular tissue. The distal andproximal portions 422 and 424 can have a rounded and/or curved shape,wherein a radius of curvature of the proximal portion 424 is larger thana radius of curvature of the distal portion 422. The distal portion 422can form, for example, a distal anchoring loop 423 that can engagedistal supra-annular tissue to at least partially stabilize and/orsecure the frame 410 in the native annulus. Although not shown in FIG.5, the proximal portion 424 similarly can form a proximal upperanchoring element that can engage proximal supra-annular tissue to atleast partially stabilize and/or secure the frame 410 in the nativeannulus.

The inner loop 425 of the supra-annular member 420 can be substantiallycircular and can be coupled to and/or suspended from the outer loop bythe one or more splines 427. As shown in FIG. 5, the inner loop 425 canbe coupled to biocompatible material 426, which can be used to couplethe inner frame 451 of the flow control component 450 to the inner loop425 of the support frame 410. In some implementations, suspending theinner loop 425 from the outer loop 421 can, for example, at leastpartially isolate the inner loop 425 (and the flow control component 450coupled to the inner loop 425) from at least a portion of the forceassociated with transitioning the frame 410 between the expandedconfiguration and the compressed configuration, as described above withreference to the frame 210.

The one or more splines 427 of the supra-annular member 420 can be anysuitable shape, size, and/or configuration. For example, in someembodiments, the supra-annular member 420 can include a proximal spline427 and one or more distal splines 427. The distal splines 427 cancouple a distal portion of the inner loop 425 to a distal portion of theouter loop 421. Similarly, the proximal spline 427 can couple a proximalportion of the inner loop 425 to a proximal portion of the outer loop421. In some embodiments, the proximal spline 427 can be configured toreceive, couple to, and/or otherwise engage an actuator and/or a portionof a delivery system. For example, the proximal spline 427 includes,forms, and/or can be coupled to a waypoint 428 that can be used tocouple to one or more portions of the actuator and/or delivery system,as described above with reference to the frames 110 and 210.

FIG. 6 is a distal perspective view illustrating the transannular member412 of the outer frame 410 of the valve 400 shown in FIG. 4. In someembodiments, the transannular member 420 of the outer frame 410 can besubstantially similar in at least form and/or function to thetransannular regions and/or members 112 and/or 212 described above.Thus, portions and/or aspects of the transannular member 412 may not bedescribed in further detail herein.

The transannular member 412 can be shaped and/or formed into a ring, acylindrical tube, a conical tube, and/or any other suitable annularshape. In some embodiments, the transannular member 412 may have a sideprofile of a concave cylinder (walls bent in), an angular hourglass, acurved, graduated hourglass, a ring or cylinder having a flared top,flared bottom, or both. Moreover, the transannular member 412 can formand/or define an aperture or central channel 414 that extends along thecentral axis 404 (e.g., the y-axis). The central channel 414 (e.g., acentral axial lumen or channel) can be sized and configured to receivethe flow control component 450 across a portion of a diameter of thecentral channel 414. In some embodiments, the transannular member 412can have a shape and/or size that is at least partially based on a size,shape, and/or configuration of the supra-annular member 420 and/orsubannular member 430 of the support frame 410, and/or the nativeannulus in which it is configured to be deployed, as described above.

The transannular member 412 can be and/or can include a wire frame thatis laser cut out of Nitinol or the like and, for example, heat-set intoa desired shape and/or configuration. The transannular member 412 can beformed to include a set of compressible wire cells 413 having anorientation and/or cell geometry substantially orthogonal to the centralaxis extending through the central channel 414 to minimize wire cellstrain when the transannular member 412 is in a vertical compressedconfiguration, a rolled and compressed configuration, or a folded andcompressed configuration. As shown in FIG. 6, the transannular member412 includes a first laser cut half 415 (e.g., an anterior side) and asecond laser cut half 416 (e.g., a posterior side) that can be formedinto a desired shape and coupled together to form the transannularmember 412. The anterior side 415 and the posterior side 416 can becoupled at one or more hinge points 417 along a distal portion and aproximal portion of the transannular member 412. More specifically, theanterior side 415 and the posterior side 416 can be coupled along thedistal side of the transannular member 412 via two sutures forming twohinge or coupling points 417 and can be coupled along the proximal sideof the transannular member 412 via one suture forming a single hinge orcoupling point 417.

In some embodiments, forming the transannular member 412 in such amanner can allow the transannular member 412 to bend, flex, fold,deform, and/or otherwise reconfigure (substantially without plasticdeformation and/or undue fatigue) in response to lateral folding alongor in a direction of a lateral or z-axis and/or vertical compressionalong or in a direction of the central or y-axis. Moreover, coupling atthe hinge points 417 using sutures can allow for a desired amount ofslippage between the sutures and the anterior/posterior sides 415/416,which in turn, can limit and/or substantially prevent binding, sticking,and/or failure in response to folding along the lateral or z-axis.

As shown in FIG. 6, the proximal portion of the transannular member 412includes a single hinge or coupling point 417. In some embodiments, thetransannular member 412 can define a gap or space 418 below the proximalhinge or coupling point 417 that can provide space to allow a proximalanchoring element of the subannular member 430 to transition between afirst configuration and a second configuration, as described in furtherdetail herein.

FIG. 7 is a distal perspective view illustrating the subannular member430 of the outer frame 410 of the valve 400 shown in FIG. 4. In someembodiments, the subannular member 430 of the frame 410 can be similarin at least form and/or function to the subannular regions and/ormembers 130 and/or 230 described above. Thus, portions and/or aspects ofthe transannular member 412 may not be described in further detailherein.

As shown, the subannular member 430 of the frame 410 includes and/orforms a distal portion having a distal anchoring element 432 and aproximal portion having a proximal anchoring element 434. The anchoringelements 432 and 434 are integrally and/or monolithically formed withthe subannular member 430. The distal anchoring element 432 and theproximal anchoring element 434 of the subannular member 430 can be anysuitable shape, size, and/or configuration such as any of thosedescribed in detail in the '957 PCT, the '010 PCT, the '231 PCT, the'390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the'345 Provisional, the '807 Provisional, any of those described abovewith reference to the frames 110 and/or 210, and/or any of thosedescribed herein with respect to specific embodiments.

The distal anchoring element 432 is shown as including an atraumatic endthat forms a guidewire coupler 433 configured to selectively engageand/or receive a portion of a guidewire or a portion of a guidewireassembly. The guidewire coupler 433, for example, is configured to allowa portion of the guidewire to extend through an opening and/or apertureof the guidewire coupler 433, thereby allowing the frame 410 to beadvanced over or along the guidewire during delivery and deployment. Insome embodiments, the guidewire coupler 433 can selectively allow theguidewire to be advanced therethrough while blocking or preventing otherelements and/or components such as a pusher or the like.

The anchoring elements 432 and/or 434 are configured to engage a desiredportion of the native tissue to mount the frame 410 to the annulus ofthe native valve in which it is deployed. For example, the distalanchoring element 432 can extend (e.g., about 10-40 mm) from thesubannular member 430 and into a RVOT or a LVOT. The distal anchoringelement 432 can be shaped and/or biased such that the distal anchoringelement 432 exerts a force on the subannular tissue operable to at leastpartially secure the distal end portion of the frame 410 in the nativeannulus.

The proximal anchoring element 434 can be configured to engagesubannular tissue on a proximal side of the native annulus to aid in thesecurement of the frame 410 in the annulus. More specifically, theproximal anchoring element 434 is configured to transition, move, and/orotherwise reconfigure between a first configuration in which theproximal anchoring element 434 extends from the subannular member 430 afirst amount or distance and a second configuration in which theproximal anchoring element 434 extends from the subannular member 430 asecond amount or distance. As described above, the subannular member 430of the frame 410 can be and/or can include, for example, a laser cutwire frame formed of a shape-memory material such as Nitinol, which isheat-set into a desired shape and wrapped in a biocompatible material(e.g., a fabric as shown in FIG. 7).

As described above, the proximal anchoring element 434 can be in acompressed, contracted, retracted, undeployed, folded, and/or restrainedstate (e.g., a position that is near, adjacent to, and/or in contactwith the transannular member 412 and/or the supra-annular member 420 ofthe support frame 410) when in the first configuration, and can be in anexpanded, extended, deployed, unfolded, and/or unrestrained state (e.g.,extending away from the transannular member 412) when in the secondstate. In some embodiments, the proximal anchoring element 434 can bebiased and/or heat-set in the second configuration. Moreover, in someimplementations, the space 418 defined by the transannular member 412 ofthe outer frame 410 is configured to provide sufficient room to allowthe proximal anchoring element 434 to transition between the first andsecond configurations.

FIGS. 8-10 illustrate at least a portion of the flow control component450 included in the valve 400 shown in FIG. 4. For example, FIG. 8 is anillustration of a top perspective view of the inner leaflet frame 451.In some embodiments, the inner leaflet frame 451 is formed of twoseparate wireframe sheets or members that are coupled at lateralconnection points 451 and 453 (e.g., fold areas, elastically deformableregions, coupled edged portions, etc.). The inner leaflet frame 451 isshown in an expanded or cylindrical configuration (e.g., prior to beingfolded and/or compressed).

Although not shown, the inner leaflet frame 451 can be transitioned fromthe expanded or cylindrical configuration to an at least partiallyfolded configuration. The inner leaflet frame 451 can have wireframesidewalls that allow for rotating or hinging at least at the lateralconnection points 451 and 453. The inner leaflet frame 451 can beconfigured to fold in response to the valve 400 being folded and/orcompressed for delivery. When transitioned, for example, to a completelyfolded configuration, the wireframe sidewalls can be rotated, hinged,and/or folded at their lateral connection points 451 and 453. Inaddition, the inner leaflet frame 451 can be vertically compressed intoa compressed configuration. The wireframe sidewalls can form cells(e.g., diamond-shaped cells or the like) that can be oriented in adirection of compression to allow for elastic compression of the innerframe 451. In some embodiments, the inner frame 451 can be verticallycompressed into a pleated or accordion (compressed) configuration.

In some embodiments, the inner leaflet frame 451 of the flow controlcomponent 450 can be formed from a linear wireframe or laser cut sheetprior to being further assembled into a cylinder structure (e.g., asshown in FIG. 8). The inner leaflet frame 451 can be formed into thecylinder structure or configuration (or a conical structure orconfiguration) with edge portions of the linear wireframe sheet beingconnected or coupled at the lateral connection points 451 and 453 (e.g.,hinge areas, fold areas, etc.). Moreover, the inner leaflet frame 451can be expanded (e.g., driven, formed, bent, etc.) from the linear sheetconfiguration into the cylinder structure or configuration.

FIGS. 9 and 10 illustrate a structural band 455 of pericardial tissuewith leaflet pockets 456 sewn into the structural band 455. FIGS. 9 and10 are a side perspective view and a bottom view, respectively,illustrating the structural band 455 and leaflet pockets 456 beforeassembly and/or mounting on and/or into the inner frame 451 to form thecollapsible (foldable, compressible) flow control component 450. FIG. 9shows the structural band 455 formed of pericardial tissue with theleaflet pockets 456 sewn into the structural band 455, after assemblyinto the cylindrical leaflet configuration, the leaflet pockets 456being disposed on an inner surface of the structural band 455. Theleaflet pocket 456 can be sewn into the structural band 455 such that anopen edge extends outward and a sewn edge forms a closed top parabolicedge providing attachment. FIG. 10 is an illustration of a bottom viewof the flow control component 450. The cylindrical structural band 455and leaflet components 456 are shown with partial coaptation towardsforming a closed fluid-seal. Although not show, the cylindricalstructural band 455 can be mounted to or in the inner leaflet frame 451(FIG. 8) to collective form the flow control component. The flow controlcomponent 450, in turn, is mounted to the outer support frame 410, asdescribed in detail above with reference to FIG. 4.

FIGS. 11-14 are sequence illustrations showing a bottom view of aprosthetic valve 500 removably coupled to an actuator 570 used toactuator one or more portions of the valve 500 according to anembodiment. The valve 500 has a subannular member 530 that can haveand/or can form a laser-cut or wire loop (and attached to sidewalls),which is/are drawn inward to reduce the perimeter or circumference ofthe at least the subannular member 530 to facilitate deployment of thevalve 500 in the native annulus. In this embodiment, the actuator 570can be and/or can include a set of tethers, tensile members, sutures,cables, and/or any other suitable connectors that can be attached to oneor more attachment points along the subannular member 530 (e.g., aproximal anchoring element of the subannular member 530). The actuator570 can also include and/or can be at least partially disposed in acatheter that can be inserted through a dynamic waypoint, opening,attachment point, through hole, etc. formed by a supra-annular member ofthe valve frame. In some implementations, the actuator 570 can be and/orcan include separate tethers used to actuate (e.g., fold) the proximalanchoring element), to actuate (e.g., fold) the septal wall sidewall,and/or to actuate (e.g., fold) the freewall sidewall.

FIGS. 11-14 show a set of tethers of the actuator 570 extending from acatheter that extends through and/or is at least partially disposedbelow a supra-annular member of the valve frame. For example, thetethers can be run through a relatively small dynamic waypoint catheterand can be actuated outside of the patient to manipulate a shape of theproximal anchoring element, the subannular member 530, and/or the valve500 to facilitate seating a proximal side of the valve 500 into thenative annulus. In some implementations, during delivery, the dynamicwaypoint catheter can be proximal to the compressed valve 500 in adelivery catheter to avoid having the dynamic waypoint catheter stackedon top of the compressed valve 500 within the delivery catheter. Anactuator with a single tether or multiple tethers is contemplated withinthe scope of the invention (e.g., one tether, two tethers, threetethers, four tethers, five tethers, six tethers, seven tethers, eighttethers, nine tethers, ten tethers, or more, each of which can beremovably coupled to one or more attachment points on the valve 500).The actuator 570 and/or the tethers may be equipped with disconnectionelements to allow the actuator 570 and/or tethers to be withdrawn afterthe valve 500 is deployed and secured in the native annulus. The dynamicwaypoint catheter may also be included in and/or housed within a portionof a delivery system such as, for example, a pusher catheter, amulti-lumen control catheter, and/or the like, whereby the dynamicwaypoint catheter can drop through the waypoint, a through hole, anopening, etc. of the valve 500 to a subannular position, while thepusher catheter, multi-lumen control catheter, and/or other portion(s)of the delivery system is too large to pass through the waypoint. Assuch, the pusher catheter, control catheter, and/or other portion(s) ofthe delivery system can be used to control a placement of at least aportion of the valve 500. For example, the pusher catheter, controlcatheter, and/or other portion of the delivery system can be used topush down onto a surface of the supra-annular member to seat theproximal side of the valve 500 in the native annulus while thesubannular member 530 is in an actuated configuration.

FIG. 11 is a bottom perspective view of the valve 500 and the actuator570 and shows the subannular member 530 in an at least partiallyextended or unactuated configuration. FIG. 12 is a bottom perspectiveview of the valve 500 and the actuator 570 and shows the subannularmember 530 partially actuated such that, for example, the proximalanchoring element of the subannular member 530 is drawn toward thedynamic waypoint catheter and/or the inner flow control component of thevalve 500. FIG. 13 is a bottom perspective view of the valve 500 and theactuator 570 and shows the subannular member 530 in a compressed,folded, and/or actuated configuration such that the proximal anchoringelement and, for example, a proximal portion of a septal wall sidewalland a freewall sidewall of the valve 500 are drawn toward the dynamicwaypoint catheter and/or the inner flow control component of the valve500. FIG. 14 is a side perspective upside down view of the valve 500 andthe actuator 570 and shows the subannular member 530 in the actuatedconfiguration, the dynamic waypoint catheter extending below thesupra-annular member of the valve frame, and the tethers retracted orpulled toward and/or into the dynamic waypoint catheter. FIG. 14 showsthat the dynamic waypoint catheter can also be used to pull the valvedown into the ventricle (e.g., via the retracted tethers), avoiding theneed to push a compressible valve into the native annulus.

While the actuator 570 is shown in FIGS. 11-14 and described above asincluding the waypoint catheter that extends through the dynamicwaypoint of the valve 500, in other implementations, the actuator 570need not include a waypoint catheter. For example, any number oftethers, cables, tension members, sutures, etc., can be routed throughone or more lumens of a multi-lumen control catheter and can extendthrough the waypoint, a through-hole, an opening, and/or the likedefined by the valve 500 to removably couple to the proximal subannularanchoring element.

FIGS. 15 and 16 are a top view and a bottom perspective view,respectively, of a side-deliverable transcatheter prosthetic valve 600removably coupled to a delivery system 680 according to an embodiment.The valve 600 includes a valve frame 610 and a flow control component650 mounted therein. The valve frame 610 includes a supra-annular member620, a subannular member 630, and a transannular member 612 coupling thesupra-annular member 620 to the subannular member 630. The deliverysystem 680 and/or at least a portion of the delivery system 680 includesa delivery catheter 682 through which the valve 600 is delivered into anatrium of a heart. The delivery system 680 further includes a connectionmember 678 that is removably coupleable to the valve 600. FIGS. 15 and16 show the connection member 678 having a wishbone or yokeconfiguration, though other configurations are possible. The connectionmember 678 can be coupled to and/or included in a distal end portion ofa multi-lumen steerable catheter, which can be used to deliver one ormore components of the valve 600 and/or the delivery system 680.

FIG. 15 shows the connection member 678 (e.g., a yoke) in contact withthe supra-annular member 620 of the valve frame 610. In someembodiments, the connection member 678 can be in contact with and/orremovably coupled to a drum or the transannular member 612 of the frame610. In other embodiments, the connection member 678 can be in contactwith and/or coupled to any suitable portion of the valve 600. Theconnection member 678 can removably couple to the valve 600 via sutures,tethers, cables, clips, couplers, and/or any other removable coupling.For example, FIG. 15 shows an attachment member 638 of the valve 600coupled to and/or extending from the supra-annular member 620. In someembodiments, the attachment member 638 of the valve 600 can be a tether,suture, cable, frame structure, and/or the like that can be coupled toand/or extend from a wire frame portion of the supra-annular member 620or, for example, a drum or biocompatible covering. In such embodiments,the connection member 678 of the delivery system 680 can be removablycoupled (e.g., via a suture, tether, and/or any other removablecoupling) to the attachment member 638 of the valve 600.

FIGS. 15 and 16 further show a guidewire catheter 684 of the deliverysystem 680 extending through, for example, a waypoint or opening in thesupra-annular member 630 and/or drum thereof and extending through aguidewire coupler 633 of a distal anchoring element 632 of thesubannular member 630. FIG. 16 shows the guidewire catheter 684extending below the flow control component 650 of the valve 600. Priorto and/or as a part of delivery, the guidewire catheter 684 can beadvanced and/or inserted through the valve 600 (as shown in FIG. 16) andadvanced over a guidewire already placed in a desired position withinthe heart. As such, delivering the valve 600 in a compressedconfiguration through the delivery catheter 682 includes advancing theguidewire catheter 684 along the guidewire. The guidewire catheter 684can extend through the guidewire coupler 633 of the distal anchoringelement 632 (e.g., a distal end of the guidewire catheter 684 can bedistal to the guidewire coupler by about 0.1 cm to about 1.0 cm, ormore).

The guidewire catheter 684 can be sufficiently stiff to, for example,limit and/or define (at least in part) a range of motion of the valve600 during delivery. For example, the guidewire catheter 684 can definean axis about which the valve 600 can rotate during delivery but cansubstantially limit or oppose movement of the valve 600 in otherdirections. In some implementations, the arrangement of the connectionmember 678 (e.g., yoke) and the guidewire catheter 684 can allow forgreater control of a position of the valve 600 during delivery. Theguidewire catheter 684 and/or one or more portions of the valve 600(e.g., the subannular member 630) can also include radiopaque markersallowing for enhanced visualization during image guided delivery. Forexample, in some instances, a radiopaque marker or wire can be placedrelative to an annular plane of the native valve and can define alandmark during image guided delivery. In such instances, the radiopaquemarkers on the guidewire catheter 684 and/or other portion(s) of thevalve 600 (e.g., the subannular member 630) can be used to align,orient, locate, index, etc. the valve 600 relative to the landmark,which in turn, corresponds to the annular plane of the native valve.Thus, image guided delivery can allow a user to visualize the valve 600during delivery and/or deployment and can allow the user to visualizewhen the valve 600 has been seated in the annulus (e.g., the radiopaquemarker bands of the valve 600 are below or in a subannular directionrelative to the radiopaque landmark.

FIG. 16 further shows an actuator 670 (or at least a portion of theactuator 670) included in the portion of the delivery system 680. Theactuator 670 can be and/or can include, for example, one or moretethers, sutures, cables, tensile members, ties, etc. removably coupledto one or more attachment points on the valve 600. For example, thetether(s) are shown removably coupled to a proximal anchoring element634 of the subannular member 630. The actuator 670 (e.g., tether(s)) canbe used to actuate the proximal anchoring element 634 between two ormore configurations, positions, states, etc. FIG. 16 shows the proximalanchoring element 634 in an expanded or unactuated configuration. Duringdeployment, an operator can actuate a proximal end portion of theactuator 670 (e.g., disposed outside of the body) to, for example, pullthe tether(s) in a proximal direction, thereby folding or compressingthe proximal anchoring element 634 toward the flow control component650. The actuation of the actuator 670 can also fold, compress, and/ordraw a proximal portion of a posterior and anterior wall of thetransannular member 612 inward toward the flow control component 650(e.g., as described above with reference to FIGS. 11-14). Afterdeploying the valve 600 in the annulus of the native valve, the actuator670 can be removed or decoupled from the valve 600, the guidewirecatheter 684 (and the guidewire extending therethrough) can be retractedthrough the waypoint or opening in the supra-annular member 620, and theportion of the delivery system 680 can be decoupled from the valve 600and withdrawn from the patient, leaving the deployed prosthetic valve600 in place in the annulus of the native heart valve.

While the valves 500 and/or 600 are described above as actuating and/ortransitioning the corresponding proximal anchoring element in aparticular manner, it should be understood that a proximal anchoringelement of a valve can be actuated, moved, swung, rotated, and/orotherwise transitioned in any suitable manner. For example, FIGS. 17-20are bottom perspective views of a prosthetic valve 700 and illustrate aprocess of transitioning a proximal anchoring element 734 of theprosthetic valve 700 between a first configuration and a secondconfiguration, according to an embodiment. The valve 700 is shown asincluding an outer support frame 710 and a flow control component 750mounted within a central region of the outer support frame 710. Theframe 710 is shown having at least a supra-annular member 720 and asubannular member 730. The supra-annular member 720 and the subannularmember 730 can be similar to any of those described above. Accordingly,certain aspects and/or features may not be described in further detailherein.

FIG. 17 shows the subannular member 730 having and/or forming a distalanchoring element 732 and the proximal anchoring element 734. Thesupra-annular member 720 is shown including a spline 727 (e.g.,extending between an outer loop and an inner loop of the supra-annularmember 720 (not shown)) that defines a waypoint 728 at or near aproximal end portion of the supra-annular member 720. The supra-annularmember 720 is further shown as including a drum 3445 that extendsbetween and/or is coupled to the inner and outer loops of thesupra-annular member 720 and covers a space not otherwise occupied bythe flow control component 750. The supra-annular member 720 (or aninner loop thereof) is shown coupled to the flow control component 750,which is distally offset relative to the valve 700.

The valve 700 is configured to engage or to be engaged by at least aportion of a delivery system 780, or the like. The delivery system 780can include any suitable component for delivering, retrieving,deploying, moving, manipulating, actuating, and/or otherwise interactingwith one or more portions of the valve 700. In this embodiment, thedelivery system 780 can include, for example, one or more catheters. Forexample, the delivery system 780 can include a delivery catheter throughwhich the valve 700 is delivered to an annulus of a native heart valve.The delivery system 780 can also include one or more steerablecatheters, control catheters, multi-lumen catheters, and/or the like, orcombinations thereof. In some embodiments, the delivery system 780 caninclude a multi-lumen control catheter that has a distal end portionconfigured to removably engage and/or couple to one or more portions ofthe valve 700 to facilitate delivery, deployment, and/or retrieval ofthe valve 700. Although not shown in FIGS. 17-20, the delivery system780 can also include a guidewire catheter that can be advanced over aguidewire during delivery and/or deployment. In such implementations,the guidewire catheter can pass through the waypoint 728, below the flowcontrol component 750, and through a guidewire coupler of the distalanchoring element, as described above with reference to the valve 600shown in FIGS. 15 and 16.

FIG. 17 further shows the delivery system 780 including an actuator 770.The actuator 770 can be similar to those described above with referenceto, for example, 170, 270, and/or 370. For example, the actuator 770 canbe and/or can include a tether that extends through the waypoint 728 ofthe spline 727 and is threaded through one or more attachment point(s)736 coupled to and/or formed along the subannular member 730. The tetherloops through the attachment(s) 736 and extends in a proximal directionback through the waypoint 728. As such, both ends of the tether can bemaintained outside of the body, allowing a user to manipulate the tether(actuator 770). In this embodiment, the tether is shown threaded throughmultiple attachment points 736 at or along the proximal anchoringelement 734 of the subannular member 730 such that actuation of theactuator 770 (e.g., tether(s)) transitions and/or moves at least theproximal anchoring element 734 between the first configuration and thesecond configuration. The tether can be threaded through the attachmentpoints 736 in any suitable manner, which in turn, can control and/ordetermine a way that the proximal anchoring element 734 is transitionedor moved. Moreover, the attachment points 736 can be formed from anysuitable material that can facilitate the passage or threading of thetether therethrough. For example, the attachment points 736 can beincluded in and/or integrally formed with a laser-cut wire frame of thesubannular member 720 (e.g., like eyelets and/or the like). In otherembodiments, the attachment points 736 can be sutured loops and/or loopsformed in or by a biocompatible fabric at least partially wrappingaround the subannular member 720. In still other embodiments, theattachment points 736 can be formed from a biocompatible polymer suchas, for example, polyethylene, and/or the like. In some suchembodiments, the biocompatible material can be, for example, aself-lubricating polymer composite and/or the like that can facilitatethe movement of the tether through the attachment point 736.

FIG. 17 shows the proximal anchoring element 734 in a first orunactuated configuration with the tether (actuator 770) looped throughthe attachment points 736 in a serpentine manner. FIGS. 18 and 19 showthe proximal anchoring element 734 as it is transitioned from the first,unactuated configuration toward a second, actuated configuration inresponse to an actuation of the actuator 770 (e.g., pulling on thetether in a proximal direction and/or in a direction that otherwiseresults in tension along a length of the tether). FIG. 20 shows theproximal anchoring element 734 in the second, actuated configuration.

In the embodiment shown in FIGS. 17-20, the actuator 770 engages theproximal anchoring element 734 such that one of the attachment points736 on an anterior or freewall side of the subannular member 730 acts asa pivot point about which the proximal anchoring element 734 is at leastpartially rotated, folded, rolled, etc. In other embodiments, theactuator 770 can engage the proximal anchoring element 734 such that anattachment point 736 on a posterior or septal side of the subannularmember 730 acts as the pivot point. In other words, the proximalanchoring element 734 can be rotated, folded, rolled, pivoted, swung,and/or otherwise moved toward an anterior side of the valve 700 or aposterior side of the valve 700 depending on how the actuator 770engages the attachment points 736 of the proximal anchoring element 734.

FIGS. 19 and 20 also show a tab 737 included on and/or formed by theproximal anchoring element 734. In some implementations, the tab 737 cancontact native subannular tissue to facilitate securement of a proximalside of the valve 700 in the annulus of the native valve. Morespecifically, the tab 737 can be positioned along and/or adjacent to theproximal anchoring element 734 and can rotate, swing, pivot, and/orotherwise move with the proximal anchoring element 734 in response toactuation of the actuator 770. In some implementations, the placement ofthe tab 737 can be such that as the proximal anchoring element 734 ismoved (e.g., from the compressed configuration to the expandedconfiguration, after the valve 700 is deployed and/or seated in theannulus), the tab 737 moves or slides behind, for example, a commissure,posterior or septal leaflets, chordae, trabeculae, and/or any otherdesirable portion of native tissue. While one tab 737 is shown in FIGS.19 and 20, in other embodiments, the proximal anchoring element 734 caninclude two or more tabs 737 that can be arranged and/or otherwise actas hooks or the like to hook onto or behind native tissue, therebysecuring the proximal anchoring element 734 to native subannular tissue.

FIGS. 21 and 22 are various views of a side-deliverable prosthetic valve800 and illustrating a portion of a supra-annular member 820 having abowed configuration, according to an embodiment. The valve 800 is shownas including an outer support frame 810 and a flow control component 850mounted within a central region of the outer support frame 810. Theframe 810 is shown having at least a supra-annular member 820, asubannular member 830, and a transannular member 812 coupledtherebetween. The frame 810 and/or aspects thereof can be similar to anyof those described above. Accordingly, certain aspects and/or featuresmay not be described in further detail herein.

The valve 800 is shown with the subannular member 830 having and/orforming a distal anchoring element 832 and a proximal anchoring element834. The distal anchoring element 832 includes a guidewire coupler 833that can receive a guidewire and/or a guidewire catheter through anopening, hole, aperture, port, etc., defined by the guidewire coupler833. In some implementations, a guidewire catheter can extend beyond thedistal anchoring element 832 and can have and/or can provide sufficientstiffness to allow the valve 800 be advanced along a guidewire that isthreaded through a lumen of the guidewire catheter. The proximalanchoring element 834 can be, for example, a movable anchoring elementconfigured to be moved and/or otherwise transitioned (e.g., by anactuator) between a first configuration and a second configuration toreduce a perimeter of the subannular member 820 during delivery and/ordeployment.

The proximal anchoring element 834 can be configured to move in anysuitable direction from the first, extended configuration (FIG. 21) tothe second, compressed configuration based at least in part on how theproximal anchoring element 834 is coupled to an actuator. For example,the proximal anchoring element 834 can be moved inward toward the innerflow control component 850, moved upward toward the supra-annular member820 and/or portion thereof, and/or moved toward an anterior side or aposterior side of the valve 800. Moreover, with the transannular member812 of the frame 810 coupled to the subannular member 830, actuation ofan actuator can, in some implementations, move one or more portions ofthe transannular member 812.

The supra-annular member 820 is shown having laser cut wire frame thatis wrapped or covered in a biocompatible material. The supra-annularmember 820 includes a distal portion 822, a proximal portion 824, anouter loop 821, an inner loop 825, and at least one spline 827. In someembodiments, the outer loop 821 can be shaped and/or sized to engagenative tissue. For example, the distal portion 822 of the supra-annularmember 820 (formed at least in part by the outer loop 821) is configuredto engage distal supra-annular tissue and the proximal portion 824(formed at least in part by the outer loop 821) is configured to engageproximal supra-annular tissue. The distal and proximal portions 822 and824 can have a rounded and/or curved shape, wherein a radius ofcurvature of the proximal portion 824 is larger than a radius ofcurvature of the distal portion 822. The distal portion 822 and/or theproximal portion 824 can form, for example, a distal supra-annularanchoring element and/or a proximal supra-annular anchoring element,respectively, each of which can engage supra-annular tissue to at leastpartially stabilize and/or secure the frame 810 in the native annulus.

The inner loop 825 of the supra-annular member 820 can have an oblong orteardrop-shape can be coupled to and/or suspended from the outer loop821 by the one or more splines 827. The inner loop 825 can be coupled tothe flow control component 850 via, for example, biocompatible material826. The inner loop 825 is shown as being coupled to the flow controlcomponent 850 such that the flow control component 850 is distallyoffset relative to the valve 800. In some implementations, suspendingthe inner loop 825 from the outer loop 821 can, for example, at leastpartially isolate the inner loop 825 (and the flow control component 850coupled to the inner loop 825) from at least a portion of the forceassociated with transitioning the frame 810 between the expandedconfiguration and the compressed configuration (e.g., during deliveryand/or deployment).

The one or more splines 827 of the supra-annular member 820 can be anysuitable shape, size, and/or configuration. For example, in someembodiments, the supra-annular member 820 can include a proximal spline827 that defines a waypoint 828. The waypoint 828 can be, for example,an opening, a hole, an aperture, a port, a coupler, asealable/resealable access point, and/or the like configured to at leasttemporarily couple to and/or receive a portion of a delivery system. Forexample, in some implementations, the portion of the delivery system caninclude at least an actuator and a guidewire catheter.

The supra-annular member 820 is further shown as including a drum 845that extends between and/or is coupled to the outer loop 821 and theinner loop 825 and covers a space not otherwise occupied by the flowcontrol component 850. FIG. 21 shows the drum 845 having and/or forminga set of spokes 845A that can be used to increase a stiffness of thedrum 845. The spokes 845A can be, for example, sutures that are sewninto the drum 845 to increase the stiffness of the drum 845 and/or tootherwise modify a deformation mode of the drum 845 during, for example,systole, which in turn, can enhance performance of the valve 800 and/orreduce fatigue in or along the drum 845. While particularly shown inFIG. 21, the spokes 845A can be arranged in any suitable manner thatresults in an increase in drum stiffness. For example, the spokes 845Acan be arranged longitudinally, laterally, and/or at angles relative toa longitudinal or lateral direction. In other embodiments, the spokes845A can be arranged in a crosshatch pattern and/or any other suitablepattern.

FIG. 21 further shows the drum 845 including an attachment member 838that can facilitate a temporary attachment to a portion of the deliverysystem. The attachment member 838 can be, for example, a braided thread,a suture, a tether, a cable, and/or the like. As described above, insome implementations, a delivery system can include a control orsteerable catheter that can include an integrated yoke or other suitableremovable coupler. More particularly, the attachment member 838 caninclude a set of loops 839 through which a set of tethers can bethreaded to removably couple the yoke of the delivery system to thevalve 800. The tethers can be passed through the loops 839 such thateach end of the tethers is maintained outside the patient allowing anoperator to manipulate the tethers to control a contact between the yokeand the drum 845.

While the attachment member 838 is shown coupled to the drum 845 at ornear a proximal edge of the drum 845, in other embodiments, theattachment member 838 can be coupled to the drum 845 in any suitablelocation (e.g., a proximal position adjacent to the flow controlcomponent 850, a distal position as shown in FIG. 21, or any suitableposition therebetween). Although the attachment member 838 is describedabove as being coupled to the drum 845, in other embodiments, anyportion of the valve 800 can include an attachment member 838. In someembodiments, for example, the supra-annular member 820 can include alaser cut portion of the wire frame that extends across a portion of theouter loop 825 (e.g., perpendicular to the spline 827).

FIGS. 21 and 22 further show the spline 827 of the supra-annular member820 having a bowed shape and/or configuration, in which the spline 827protrudes away from the subannular member 820. For example, in someembodiments, a laser cut frame of the supra-annular member 820 can beformed with the spline 827 having the bowed configuration. In someimplementations, bowed spline 827 can exert a force on the drum 845 thatbows the drum 845 and increases a tension across the area of the drum845. The increase in tension, in turn, increases a relative stiffness ofthe drum 845, which can reduce and/or limit an amount of drumdeformation during, for example, diastole or systole, thereby enhancingperformance of the valve 800 and/or reduce fatigue in or along the drum845. Said another way, the pressure produced on the atrial side of thedrum 845 during contraction of the atrium (diastole) is not sufficientto invert the bowed configuration of the drum 845 (i.e., will notproduce an oil-can like deflection) due to the bowed spline 827. Thebowed configuration of the drum 845 can also withstand the greaterpressure produced on the ventricle side of the drum 845 duringcontraction of the ventricle (systole) without substantial deflection.Moreover, the bow in the spline 827 can be such that the waypoint 828 ispositioned at a desired angle and/or orientation to facilitate theinsertion or retrieval of one or more portions of the delivery systemthrough the waypoint 828.

The valves described herein are configured to be delivered to a desiredtarget location within a patient via side or orthogonal deliverytechniques, methods, and/or systems. A delivery system forside-delivering a transcatheter prosthetic valve can be any shape, size,and/or configuration, and can include any suitable feature, component,member, mechanism, assembly, subsystem, and/or the like. In someimplementations, a delivery system can be similar to and/or can includeany suitable combination of components from the delivery systemsdescribed in any of the '957 PCT, the '010 PCT, the '231 PCT, the '390PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the '345Provisional, and/or the '807 Provisional.

For example, FIGS. 23A-23C are schematic illustrations of aside-deliverable prosthetic valve 900 and at least a portion of adelivery system 980 for side-delivering the prosthetic valve to anannulus of a native heart valve, according to an embodiment. Theside-deliverable prosthetic valve 900 (“valve”) can be, for example,substantially similar to the valves 100, 400, 500, 600, 700, and/or 800.For example, the valve 900 can have an outer frame with an inner flowcontrol component mounted therein. The valve 900 is compressible andexpandable in at least one direction relative to a longitudinal axis, asdescribed in further detail herein.

The delivery system 980 can include any suitable component(s) configuredto place the valve 900 in a delivery configuration, load the valve 900into a portion of the delivery system 980, deliver the valve 900 in thedelivery configuration through a portion of the delivery system 980,control and/or facilitate a deployment of the valve 900 in the annulusof the native valve, and in some instances, at least partially retrievethe valve 900 from the annulus to allow for adjustment and/or reseatingof the valve 900 or removal of the valve 900 from the heart (e.g., inthe case of failure or patient distress).

In the embodiment shown in FIGS. 23A-23C, the delivery system 980includes at least a control device 970, a compression device 990, aloading device 960, and a delivery device 981. The control device 970can be and/or can include any number of components that can be at leasttemporarily coupled to and/or in contact with one or more portions ofthe valve 900 and configured to control and/or facilitate, for example,a delivery, deployment, and/or retrieval of the valve 900. For example,in some embodiments, the control device 970 can include a controlcatheter that includes a connection member disposed at a distal end ofthe control catheter. In some embodiments, the connection member canhave a wishbone or yoke configuration, though other configurations arepossible.

The connection member is removably coupleable to the valve 900. Morespecifically, the connection member can be removably coupled to andplaced in contact with a supra-annular member or region of the valveframe. In some embodiments, the connection member can be in contact withand/or removably coupled to a drum extending across the supra-annulusmember or region, a transannular member or region of the frame, and/orany other suitable portion of the valve 900. The connection member canremovably couple to the valve 900 via sutures, tethers, cables, clips,couplers, and/or any other removable coupling. For example, in someembodiments, the valve 900 can include one or more attachment memberssuch as a tether, suture, cable, frame structure, drum structure, and/orthe like to which the connection member of the control device 970 can beremovably coupled (e.g., via a suture, tether, and/or any otherremovable coupling).

The control device 970 can include a control catheter that is coupled toand/or that otherwise includes the connection member at a distal endthereof. In some embodiments, the control catheter can be a steerable,multi-lumen catheter. The multiple lumens can be configured to provideone or more paths through which one or more components can extend toselectively engage the valve 900. For example, as shown in FIG. 23A, thedelivery system 980 can include a guidewire catheter 984 that extendsthrough a lumen of the control catheter and through one or more portionsof the valve 900. More particularly, the guidewire catheter 984 canextend through a waypoint or opening defined in or by the supra-annularmember or region of the valve 900, can traverse a distance below theinner flow control component of the valve 900, and can extend through,for example, a guidewire coupler included in distal subannular anchoringelement, as described in detail above with reference to the valve 600shown in FIGS. 15 and 16.

In addition, one or more of the lumens of the multi-lumen controlcatheter can receive a tether, suture, wire, etc., configured to loopthrough a portion or side of the connection member (e.g., a yoke),around an attachment point of the valve 900, through the portion or sideof the connection member again, back through the same lumen of thecontrol catheter, thereby coupling the connection member to the valve900. Moreover, such an arrangement can allow an operator to pull on oneend of the tether, suture, wire, etc., (“tether”) to remove the tetherfrom the control device 970, which in turn, can at least partiallydecouple the connection member from the valve 900 (e.g., after asuccessful deployment of the valve). Similarly, one or more of thelumens of the control catheter can receive an actuator, tension member,tether, cable, wire, etc., that can be routed through a lumen of thecontrol catheter to engage a proximal anchoring element of the valve900. Accordingly, the tension member or the like can be actuated (e.g.,placed under tension) to transition the proximal anchoring elementbetween two or more configurations, as described in detail above withreference to the valves 500, 600, and/or 700.

FIG. 23A shows the compression device 990 removably coupled to theloading device 960 and shows the valve 900 at least partially disposedin a lumen 995 of the compression device 990. In some implementations,it is desirable to couple the control device 970 to the valve 900 priorto inserting the valve 900 into the compression device 990. As such, thecompression device 990 can be, for example, a multi-component devicethat can be separated to allow the compression device 990 to bedecoupled from the loading device 960 and from around at least a portionof the control device after the valve 900 has been advancedtherethrough, as described in further detail herein.

FIG. 23A shows the lumen 995 of the compression device 990 being taperedin at least one direction as the lumen extends from a proximal end ofthe compression device 990 to a distal end of the compression device990. In some embodiments, for example, the lumen 995 can be tapered inone direction such as an axial direction (e.g., a direction parallel toa flow of fluid through the valve) that is orthogonal to a longitudinaldirection (e.g., a proximal-distal direction). In such embodiments, asize and/or perimeter of the lumen 995 at the proximal end of thecompression device 990 can be such that an operator or user compressesand/or folds the valve 900 in a lateral direction orthogonal to both theaxial and longitudinal directions prior to inserting the valve 900 intothe proximal end of the compression device. In other embodiments, thelumen 995 can be tapered in two directions—namely, the axial directionand the lateral direction. In either embodiment, a size and/or perimeterof the lumen 995 at the proximal end of the compression device 990 islarger than a size and/or perimeter of the lumen 995 at a distal end ofthe compression device 990. Moreover, in some embodiments, a shape ofthe lumen 995 at the proximal end of the compression device 990 can bedifferent from a shape of the lumen at the distal end of the compressiondevice 990. For example, in some embodiments, the lumen 995 at theproximal end of the compression device 990 can have a substantiallyrectangular perimeter while the lumen 995 at the distal end of thecompression device 990 can have a substantially circular perimeter. Inother embodiments, the lumen 995 can have substantially the same shapeat the proximal end and the distal end or can have any suitablecombination of shapes at the proximal and distal ends.

In some implementations, after initially inserting the valve 900 intothe proximal end of the compression device 990 a user or operator can,for example, exert a force on the control device 970 such that theconnection member (e.g., a yoke) pushes the valve 900 through thecompression device 990. In other implementations, the control device 970can include a pusher and/or the guidewire catheter 984 can include apusher that can selectively engage a portion of the distal subannularanchoring element to pull the valve 900 through the compression device990 in response to a distally directed force exerted on the controldevice 970. In some implementations, the delivery system 980 can includea pulling device and/or the like (not shown) that can be removablycoupled to a distal portion of the loading device 960 and a distal endof the valve 900 (e.g., via a tether or the like) and can be manipulatedto pull the valve 900 through the compression device 990. In someimplementations, the pulling device can be used to pull the valve 900and the control device 970 can be used to push and/or pull the valve 900to collectively advance the valve 900 through the compression device990.

The valve 900 is shown in FIG. 23A as being advanced through the lumen995 of the compression device 990 from the proximal end to the distalend and the compression device 990 compresses the valve 900 in at leastthe axial direction as the valve 900 is advanced therethrough. In someinstance, the valve 900 can be in a substantially uncompressed or alaterally compressed configuration when inserted into the proximal endof the compression device 990 and can be compressed to a compressed ordelivery configuration when advanced to and/or through the distal end ofthe compression device 990. Although not shown, in some instances, thevalve 900 can be loaded into the compression device 990 and advancedthrough the lumen 995 while at least the compression device 990 isdisposed in a saline bath or the like, which can facilitate theadvancement of the valve 900 through the compression device 990 and canmaintain a substantial sterility of the valve 900.

FIG. 23A shows a proximal end of the loading device 960 being removablycoupled to the distal end of the compression device 990. The loadingdevice 960 can be any suitable shape, size, and/or configuration. FIG.23A shows the loading device 960 as defining a lumen 963 that extendsthrough the loading device 960 and having a gate 966 at a distal end ofthe loading device 960. The gate 966 is movable between a closed state(FIGS. 23A and 23B) and an open state (FIG. 23C). The gate 966 in theclosed state can selectively occlude a portion of the lumen 963, asdescribed in further detail herein.

The distal end of the loading device 960 is further shown as includingat least one port 967. The at least one port 967 is in fluidcommunication with the lumen 963 and is configured to provide selectiveflushing of at least a portion the lumen 963. In some embodiments, forexample, the loading device 960 can include a first port that isdisposed proximal to the gate 966 and in fluid communication with atleast a portion of the lumen 963 proximal to the gate 966, and a secondport that is disposed distal to the gate 966 and in fluid communicationwith at least a portion of the lumen 963 distal to the gate 966. In someimplementations, the port 967 (e.g., via a first portion of the port 967or a first port) can be used to provide suction to at least a portion ofthe lumen 963 as well as a flow of fluid for flushing at least a portionof the lumen 963 (e.g., via a second portion of the port 967 or a secondport). In some instances, the port 967 can provide flushing (e.g., aflow of sterile fluid such as saline with or without simultaneoussuctioning) of at least a portion of the lumen 963 while the gate 966 isin the closed state and/or after the gate 966 is transitioned to theopen state.

The lumen 963 of the loading device 960 has a diameter and/or perimeterthat is substantially similar to a diameter and/or perimeter of thelumen 995 at the distal end of the compression device 990. As such, thevalve 900 can be compressed to the delivery configuration and advancedfrom the compression device 990 into the lumen 963 of the loading device960. FIG. 23B shows the valve 900 in the delivery configuration disposedin the lumen 963 of the loading device 900. FIG. 23B further shows thatthe compression device 990 is removed and/or decoupled from the proximalend of the loading device 960 after the valve 900 is advanced into thelumen 963. In some implementations, for example, the compression device990 can be laterally separated and removed from around the controldevice 970 and withdrawn from the loading device 960, as describedabove. Although not shown in FIGS. 23A-23B, after removing thecompression device 990 from the loading device 960, a hemostasis valveand/or the like can be advanced over a portion of the control device 970and coupled to the proximal end of the loading device 960. Thehemostasis valve and/or the like can form a substantially fluid tightseal at the proximal end of the loading device 960 (e.g., and around thecontrol device 970 and/or a control catheter thereof). Moreover, inimplementations in which a pulling device or the like is coupled to thedistal end of the loading device 960 to pull the valve 900 into theloading device, the pulling device can be decoupled from the loadingdevice 960 and any tether, cable, and/or connection attached to thedistal end of the valve 900 can be removed therefrom.

FIG. 23B shows that the valve 900 is loaded into the loading device 960while the gate 966 is in the closed state. In some implementations, thevalve 900 can be advanced through the lumen 963 until, for example, thedistal anchoring element (or a distal most portion) of the valve 900contacts and/or is adjacent to a proximal surface of the gate 966 in theclosed state. FIG. 23B further shows that the guidewire catheter 984extends distally from the valve 900, through the gate 966 in the closedstate, and beyond the distal end of the loading device 960. In someembodiments, for example, the gate 966 can have a shape and/or size suchthat a space is defined between an edge of the gate 966 and an innersurface of the loading device 960 allowing the guidewire catheter 984 toextend therethrough. In some embodiments, the gate 966 can define anopening, a hole, a notch, a recess, and/or the like through which theguidewire catheter 984 can extend.

FIGS. 23B and 23C show that the distal end of the loading device 960 canbe coupled to a proximal end of the delivery device 981. In someimplementations, the delivery device 981 and/or at least a deliverycatheter thereof can be inserted into the patient and advanced throughthe patient such that a distal end of the delivery device 981 (deliverycatheter) is disposed in a space or volume of a heart. Moreover, thedelivery device 981 and/or at least the delivery catheter thereof can betracked and/or advanced over a guidewire 985 that is previously insertedthrough the patient and placed in a desired position relative to anannulus of the native heart valve. FIG. 23B shows that a proximal end ofthe guidewire 985 extends from the proximal end of the delivery device981. As described above, in some instances, the valve 900 is loaded intothe loading device 960 while the compression device 990 and the loadingdevice 960 are disposed in a fluid (e.g., saline) bath. In suchinstances, the loading device 960 with the valve 900 in the deliveryconfiguration disposed in the lumen 963, the hemostasis valve or thelike coupled to the proximal end, and the gate 966 in the closed statecan be removed from the bath and brought to, for example, an operatingtable or the like to be coupled to the proximal end of the deliverydevice 981 that is already inserted into the patient.

FIG. 23B shows that prior to coupling the distal end of the loadingdevice 960 to the delivery device 981 the guidewire 985 extendingthrough the proximal end of the delivery device 981 is inserted into theguidewire catheter 984. The delivery device 981 is shown as defining alumen 983 that has a perimeter and/or diameter that is substantiallysimilar to the perimeter and/or diameter of the lumen 963 of the loadingdevice 960. FIG. 23B shows that the proximal end of the delivery device981 includes a gate 966 that is movable between a closed state (FIG.23B) and an open state (FIG. 23C). The proximal end of the deliverydevice 981 is further shown as including at least one port 987. The atleast one port 987 is in fluid communication with the lumen 983 and isconfigured to provide selective flushing of at least a portion the lumen983. In some embodiments, for example, the delivery device 981 caninclude a first port that is disposed proximal to the gate 986 and influid communication with at least a portion of the lumen 983 proximal tothe gate 986, and a second port that is disposed distal to the gate 986and in fluid communication with at least a portion of the lumen 983distal to the gate 986. In some implementations, the port 987 (e.g., viaa first portion of the port 987 or a first port) can be used to providesuction to at least a portion of the lumen 983 as well as a flow offluid for flushing at least a portion of the lumen 983 (e.g., via asecond portion of the port 987 or a second port), as described abovewith reference to the loading device 960.

FIG. 23B shows that the distal end of the loading device 960 is coupledto the proximal end of the delivery device 981 while each of the gates966 and 986 are in the closed state. In some implementations, aftercoupling the loading device 960 to the delivery device 981, a volumecollectively defined by the lumens 963 and 983 disposed between thegates 966 and 986 in the closed state can be flushed via the ports 967and 987. For example, in some implementations, the port 987 can providea flow of saline and/or other sterile fluid into the volume while theport 967 can provide a suction to and/or through at least the volume (orvice versa).

FIG. 23C shows that after coupling the loading device 960 to thedelivery device 981 and after flushing the volume defined between thegates 966 and 986, the gates 966 and 986 can be transitioned from theclosed state to the open state. As such, the lumens 963 and 983 aresubstantially open or otherwise not occluded. Thus, a user and/oroperator can exert a distal force on a portion of the control device 970to advance the valve 900 in the delivery configuration from the loadingdevice 960 and into the lumen 983 of the delivery device 981. Moreover,the distal force can be operable to advance the valve 900 through adelivery catheter of the delivery device (not shown) and to release thevalve 900 from a distal end thereof. Once released (or at leastpartially released), the control device 970 can control and/ormanipulate the valve 900 to seat the valve in the annulus of the nativeheart valve.

In some instances, it may be desirable to at least partially retrievethe valve 900 from the annulus during deployment (e.g., to adjust aposition, orientation, and/or seating of the valve 900 in the annulus).In such instances, the control device 970 further can be used to atleast partially retrieve the valve 900 into the distal end of thedelivery catheter (included in the delivery device). For example, withthe connection member (e.g., a yoke) coupled to a portion of the valve900, the user and/or operator can exert a proximally directed force onthe control device 970 that can pull that valve 900 proximally towardand/or into the delivery catheter. Moreover, the delivery system 980 caninclude any suitable capture element, feature, member, mechanism, etc.configured to facilitate a compression of the valve 900 as the valve 900is pulled in a proximal direction toward and/or into the deliverycatheter. In some instances, after partially retrieving the valve 900,the control device 970 can be manipulated to reseat the valve 900 in theannulus in a desired orientation and/or configuration.

FIG. 24-39 illustrate various portions of a delivery and/or retrievalsystem 1080 for delivering, deploying, and/or at least partiallyretrieving a prosthetic valve 1000, according to an embodiment. Thedelivery and/or retrieval system 1080 (“delivery system”) can be anysuitable shape, size, and/or configuration and can include any suitablecomponent or combination of components. In some embodiments, forexample, the delivery system 1080 and/or at least portions or aspectsthereof can be similar to and/or substantially the same as the deliverysystem 980 described above with reference to FIGS. 23A-23C. Accordingly,portions and/or aspects of the delivery system 1080 may not be describedin further detail herein. Moreover, the delivery system 1080 can be usedto delivery, deploy, and/or at least partially retrieve any suitablevalve such as, for example, any of the valves 100, 400, 500, 600, 700,800, and/or 900. For example, the valve 1000 can have an outer framewith an inner flow control component mounted therein. The valve 1000 iscompressible and expandable in an axial direction and a lateraldirection relative to a longitudinal axis of the valve 1000, asdescribed in further detail herein.

The delivery system 1080 can include any suitable component(s)configured to place the valve 1000 in a delivery configuration, load thevalve 1000 into a portion of the delivery system 1080, deliver the valve1000 in the delivery configuration through a portion of the deliverysystem 1080, control and/or facilitate a deployment of the valve 1000 inthe annulus of the native valve, and in some instances, at leastpartially retrieve the valve 1000 from the annulus to allow foradjustment and/or reseating of the valve 1000 or removal of the valve1000 from the heart (e.g., in the case of failure or patient distress).

FIG. 24 is a partially exploded perspective view of the delivery system1080. As shown, the delivery system 1080 includes a dilator 1058, aloading device 1060, a control device 1070, a delivery device 1081, acompression device 1090, a guidewire catheter 1084, and a pulling device1098. The dilator 1058 can be any suitable dilator configured to dilateat least a portion of a pathway within the body to allow, for example, adelivery catheter and/or other relatively large gauge catheter to beadvanced through the pathway. In this embodiment, the dilator 1058 canbe configured to dilate a pathway through, for example, the femoral veinand the IVC to allow a delivery catheter 1082 of the delivery device1081 to be advanced into a heart of the patient.

The pulling device 1098 can be any suitable device configured toremovably couple to the valve 1000 to facilitate advancement (e.g., apulling) of the valve 1000 through one or more portions of the deliverysystem 1080. For example, in some embodiments, the pulling device 1098can include a tether (e.g., a suture, tension member, cable, wire, etc.)that can be coupled to a distal end of the valve 1000 at a first end. Anopposite end of the tether can be coupled to the pulling device 1098,which can be and/or can include a spool mechanism or the like aboutwhich at least a portion of the tether can be spooled or wound. Asdescribed in further detail herein, the spooling and/or winding of thetether can be operable to pull the valve 1000 through the one or moreportions of the delivery system 1080.

FIGS. 25A-25E and 26A-26G show various views and/or aspects of thecompression device 1090. As described above, the valve 1000 can beinserted into the compression device 1090 to transition the valve 1000from an uncompressed or a partially compressed (e.g., laterallycompressed) configuration to a compressed or delivery configuration. Thecompression device 1090 is shown including a first member 1091, a secondmember 1091, and a coupler 1092. The compression device 1090 can have afunnel-like shape and defines a lumen 1095 that extends through aproximal end and a distal end of the compression device. FIGS. 25A-25Cshow that the coupler 1092 can be removably disposed about at least aportion the first member 1091 and the second member 1092 to couple themembers 1091 and 1092 together. FIG. 25A shows that the funnel-likeshape of the compression device 1090 allows the coupler 1092 to be slidover a portion of the first member 1091 and the second member 1092 andadvanced to a position in which an outer surface of the compressiondevice 1090 collectively formed by the first and second members 1091 and1092 forms a friction fit with an inner surface of the coupler 1092,thereby forming the compression device 1090. FIG. 25B shows that thecoupler 1092 can be removed from the first member 1091 and the secondmember 1092 in, for example, a distal direction.

FIG. 25C shows that the first member 1091 and the second member 1092 arelaterally separable. That is to say, the first member 1091 and thesecond member 1092 are separable about a plane that extends in alongitudinal direction (e.g., proximal-distal direction) and an axialdirection, and orthogonal to a lateral axis and/or direction. The firstmember 1091 and the second member 1092 are shown as having asubstantially mirrored arrangement. Moreover, an inner surface of thefirst member 1091 and an inner surface of the second member 1092collectively define the lumen 1095.

FIG. 25D is a proximal view of the compression device 1090 and shows thelumen 1095 extending through the proximal end of the compression device1090. The lumen 1095 at the proximal end has a substantially rectangularshape. Specifically, the lumen 1095 and/or the perimeter of the lumen1095 has an axial dimension that substantially corresponds to an axialheight of the valve 1000 configured to be inserted therein. In someembodiments, the axial dimension can be slightly larger than the axialheight of the valve 1000 allowing the valve 1000 to be substantiallyuncompressed in the axial direction when inserted into the proximal endof the compression device 1090. In other embodiments, the axialdimension can be slightly smaller than the axial height of the valve1000 such that inserting the valve 1000 into the proximal end of thecompression device 1090 includes at least slightly compressing the valve1000 in the axial direction.

The lumen 1095 and/or the perimeter of the lumen 1095 at the proximalend has a lateral dimension that substantially corresponds to a lateralwidth of the valve 1000 configured to be inserted therein. Morespecifically, the lateral dimension substantially corresponds to a widthof the valve 1000 in a laterally compressed configuration. As describedin detail above, the valve 1000 can be compressed and/or folded in thelateral direction. In this embodiment, the lateral dimension of thelumen 1095 at the proximal end is such that the valve 1000 is manuallycompressed and/or folded prior to being inserted into the proximal endof the compression device 1090.

FIG. 25E is a distal view of the compression device 1090 and shows thelumen 1095 extending through the distal end of the compression device1090. The lumen 1095 at the distal end has a substantially circularshape. Specifically, the lumen 1095 and/or the perimeter of the lumen1095 has a size and/or diameter that substantially corresponds to aperimeter and/or axial-lateral extent of the valve 1000 in the deliveryconfiguration. In some embodiments, a lateral dimension of the lumen1095 at the distal end of the compression device 1090 (e.g., thediameter of the lumen 1095 at the distal end) can be substantially thesame as the lateral dimension of the lumen 1095 at the proximal end ofthe compression device 1090. Accordingly, in such embodiments, thecompression device 1090 is configured to compress the valve 1000 in theaxial direction. In other embodiments, the diameter of the lumen 1095 atthe distal end can be smaller than the axial dimension and the lateraldimension of the lumen 1095 at the proximal end. The decreasing sizeand/or perimeter of the lumen 1095 of the compression device 1090 isconfigured to transition the valve 1000 to a compressed or deliveryconfiguration as the valve 1000 is advanced therethrough.

FIG. 26A is a side view of the compression device 1090 and shows threeplanes 26B-26B, 26D-26D, and 26F-26F along a length of the compressiondevice 1090 corresponding to cross-sectional views that show a sizeand/or shape of the lumen 1095 at the location of the planes. Forexample, FIG. 26B is a cross-sectional view of the compression device1090 taken along the plan 26B-26B in FIG. 26A. The lumen 1095 of thecompression device 1090 is shown as being substantially rectangular withcorners that are more rounded than the corresponding corners of thelumen 1095 at the proximal end of the compression device 1090 (see e.g.,FIG. 25D). The lumen 1095 is further shown as having a perimeter with anaxial dimension (e.g., a maximum axial dimension) and a lateraldimension (e.g., a maximum lateral dimension) that are substantiallysimilar to the perimeter of the lumen 1095 at the proximal end. FIG. 26Cshows the valve 1000 in a partially compressed configurationcorresponding to the perimeter of the lumen 1095 shown in FIG. 26B. Forexample, the valve 1000 can be laterally compressed with little to noaxial compression.

FIG. 26D is a cross-sectional view of the compression device 1090 takenalong the plan 26D-26D in FIG. 26A. The lumen 1095 of the compressiondevice 1090 is shown as being substantially elliptical or oval-shapedwith corners that are more rounded than the corresponding corners of thelumen 1095 at the position shown in FIG. 26B. The lumen 1095 is furthershown as having a perimeter with a lateral dimension (e.g., a maximumlateral dimension) that is substantially similar to the lateraldimension of the perimeter of the lumen 1095 at the proximal end. FIG.26D shows that the perimeter of the lumen 1095 has an axial dimension(e.g., a maximum axial dimension) that is smaller than the axialdimension of the perimeter of the lumen 1095 at the position shown inFIG. 26B. FIG. 26E shows the valve 1000 in a partially compressedconfiguration corresponding to the perimeter of the lumen 1095 shown inFIG. 26D. For example, the valve 1000 can be compressed in the lateraldirection and partially compressed in the axial dimension.

FIG. 26F is a cross-sectional view of the compression device 1090 takenalong the plane 26F-26F in FIG. 26A. The lumen 1095 of the compressiondevice 1090 is shown as being substantially circular with a perimeterand/or diameter that is substantially similar to the perimeter and/ordiameter of the lumen 1095 at the distal end of the compression device1090 (see e.g., FIG. 25E). FIG. 26G shows the valve 1000 substantiallyin a compressed and/or delivery configuration corresponding to theperimeter of the lumen 1095 shown in FIG. 26G. Thus, the compressiondevice 1090 is configured to compress the valve 1000 to the deliveryconfiguration as the valve 1000 is advanced therethrough. As describedin further detail herein, the control device 1070 and/or the pullingdevice 1098 can be used to push, pull, and/or otherwise advance thevalve 1000 through the compression device 1090.

FIG. 27 is a perspective view of the loading device 1060 included in thedelivery system 1080. The loading device 1060 has a distal end and aproximal end and defines a lumen 1063 that extends through the loadingdevice 1060. The lumen 1063 has a substantially circular perimeter witha diameter that is similar to and/or substantially the same as thediameter of the lumen 1095 at the distal end of the compression device1090. The proximal end of the loading device 1060 is configured to beremovably coupled to the distal end of the compression device 1090 andthe distal end of the loading device is configured to be removablycoupled to each of the pulling device 1098 and the delivery device 1081(e.g., one at a time), as described in further detail herein. FIG. 27further shows the proximal end of the loading device 1060 including agate 1066 that is movable between an open state and a closed state to atleast partially occlude the lumen 1063 of the loading device 1060, asdescribed in further detail herein. The proximal end of the loadingdevice 1060 is also shown as including a set of ports 1067, to whichsterile flexible tubing is coupled, that can be used to flush and/orsuction at least a portion of the lumen 1063, as described in furtherdetail herein.

FIG. 28 is a perspective view of the delivery device 1081 included inthe delivery system 1080. The delivery device 1081 includes a handle1088 and a delivery catheter 1082 extending from a distal end of thehandle 1081. The handle 1088 and the delivery catheter 1082 collectivelydefine a lumen 1083 that extends through the delivery device 1081. Thelumen 1083 has a substantially circular perimeter with a diameter thatis similar to and/or substantially the same as the diameter of the lumen1063 of the loading device 1060. The proximal end of the handle 1088 isconfigured to be removably coupled to the distal end of the loadingdevice 1060, as described in further detail herein. FIG. 28 furthershows the proximal end of the handle 1088 including a gate 1086 that ismovable between an open state and a closed state to at least partiallyocclude the lumen 1083 of the delivery device 1081, as described infurther detail herein. The proximal end of the handle 1088 is also shownas including a set of ports 1087, to which sterile flexible tubing iscoupled, that can be used to flush and/or suction at least a portion ofthe lumen 1083, as described in further detail herein. The proximal endof the handle 1088 is also shown including a coupler with an indexingfeature 1089 configured to align the delivery handle 1088 when coupledto the loading device 1060. The indexing feature 1089 is shown as a slotthat can receive a corresponding indexing feature (e.g., a protrusion)included in the distal end of the loading device 1060. In this manner,the delivery device 1081 and the loading device 1060 can be in apredetermined and/or desired orientation when coupled.

FIGS. 29-34B illustrate various portions of the control device 1070included in the delivery system 1080. The control device 1070 can beand/or can include any number of components that can be at leasttemporarily coupled to and/or in contact with one or more portions ofthe valve 1000 and configured to control and/or facilitate, for example,a delivery, deployment, and/or retrieval of the valve 1000. For example,in some embodiments, the control device 1070 can include a controlcatheter 1071 that has a connection member 1078 disposed at a distal endof the control catheter 1071 and a control portion 1072 at a proximalend of the control catheter 1071.

The control portion 1072 can be any suitable shape, size, and/orconfiguration and can provide a way for a user and/or operator to engageone or more portions of the control device 1072. The control portion1072 is shown having a number of control arms 1077, each of which canreceive and provide a way of controlling a portion of the control device1070 such as, for example, one or more tethers, tension members, cables,wires, sutures, etc.

The control catheter 1071 can be a steerable, multi-lumen catheter. Forexample, FIG. 30 is a cross-sectional view of the control catheter 1071taken along the line 30-30 in FIG. 29. The control catheter 1071 isshown as including a set of tether or tension member lumens 1073 and aguidewire catheter lumen 1074. Each tether or tension member lumen 1073is in communication with a different and/or corresponding control arm1077 of the control portion 1072, which provides proximal access to thecorresponding lumen 1073. The tether or tension member lumens 1073 areshown as having a smaller diameter than the guidewire catheter lumen1074 and extending through a sidewall portion of the control catheter1071 between an outer surface and an inner surface defining theguidewire catheter lumen 1074. The tether or tension member lumens 1073provide one or more paths through which one or more tethers, tensionmembers, cables, wires, sutures, etc. can extend to selectively engageportions of the valve 1000, as described in further detail herein. Theguidewire catheter lumen 1074 extends through the control portion 1072of the control device 1070 and provides a path through which theguidewire catheter 1084 can extend to allow a distal end of theguidewire catheter 1084 to engage and/or extend through one or moreportions of the valve 1000, as described in further detail herein.

FIGS. 31A-31C are perspective views of the distal end of the controldevice 1070 and illustrate the connection member 1078 transitioningbetween an expanded configuration and a compressed configuration. Theconnection member 1078 can be formed from any suitable material such asa shape-memory allow like nitinol or the like. FIG. 31A shows theconnection member 1078 having a wishbone or yoke design as describedabove, for example, with reference to the connection member 678 shown inFIG. 15. As such, the connection member 1078 can have a first portion,side, and/or arm and a second portion, size, and/or arm opposite thefirst portion, side, and/or arm. FIG. 31A shows the connection member1078 in the expanded configuration. FIG. 31B shows the connection member1078 beginning to be transitioned from the expanded configuration to thecompressed configuration in response to the delivery catheter 1082 beingdisposed at or near the distal end of the control device 1070. FIG. 31Cshows the connection member 1078 in the compressed configuration whenthe connection member 1078 is at least partially disposed in the lumenof the delivery catheter 1082. A diameter of the lumen of the deliverycatheter 1082 is smaller than a width of the connection member 1078 inthe expanded configuration and thus, the delivery catheter 1082 is shownsqueezing the connection member 1078 into the compressed configurationwhen the connection member 1078 is at least partially disposed in thedelivery catheter 1082. The connection member 1078 in the compressedconfiguration allows the control catheter 1071 to be advanced throughthe delivery catheter 1082 and the connection member 1078 canautomatically transition from the compressed configuration to theexpanded configuration when released from and/or otherwise moved to adistal position relative to the delivery catheter 1082.

FIG. 32 is a perspective view of the distal end of the control device1070 and illustrates the connection member 1078 and a set of tethers1075 extending from corresponding tether and/or tension member lumens1073 of the control catheter 1071. The tethers 1075 are shown extendingfrom the control catheter 1071, looping through a set of openings 1079defined along or by each side or arm of the connection member 1078(yoke), and extending back into the corresponding tether and/or tensionmember lumen 1073. The tethers 1075 can be used to removably connect theconnection member 1078 to the valve 1000.

FIG. 33 is a side perspective view of the distal end of the controldevice 1070 showing the connection member 1078 removably coupled to thevalve 1000. The valve 1000 is shown having an outer frame 1010 with aflow control component 1050 mounted therein, as described above withreference to the valves 400, 500, 600, 700, and/or 1000. The frame 1010has a supra-annular region 1020 and a subannular region 1030 with atransannular region coupled therebetween.

The supra-annular region 1020 is shown having a laser cut frame that iswrapped or covered in a biocompatible material. The supra-annular region1020 includes a proximal spline 1027 that extends between an outer loopand an inner loop of the supra-annular region 1020, as described abovewith reference to the valve 800. The flow control component 1050 isshown mounted to the inner loop of the supra-annular region 1020. Thespline 1027 is shown having a bowed configuration and defining awaypoint 1028. The waypoint 1028 can be, for example, an opening, ahole, an aperture, a port, a coupler, a sealable/resealable accesspoint, and/or the like configured to at least temporarily couple toand/or receive a portion of the delivery system 1080.

The supra-annular region 1020 is further shown as including a drum 1045that extends between and/or is coupled to the outer loop and the innerloop and covers a space not otherwise occupied by the flow controlcomponent 1050. The drum 1045 can have and/or can form a set of spokesthat can be used to increase a stiffness of the drum 1045, as describedabove with reference to the valve 800. The bowed spline 1027 can exert aforce on the drum 1045 that bows the drum 1045 and increases a tensionacross the area of the drum 1045. The increase in tension in the drum105 and the increase in stiffness of the drum 1045 due to the spokescan, in turn, reduce and/or limit an amount of drum deformation during,for example, diastole or systole, thereby enhancing performance of thevalve 1000 and/or reduce fatigue in or along the drum 1045, as describedin detail above with reference to the valve 800. The supra-annularregion 1020 and/or the drum 1045 is further shown having an attachmentmember 1038 that can extend along or across a portion of the drum 1045.The attachment member 1038 facilitates a temporary and/or removableattachment to a portion of the control device 1070. The attachmentmember 1038 can be, for example, a braided thread, a suture, a tether, acable, and/or the like that can include and/or form a set of loops 1039or the like allowing for selective engagement of the attachment member1038.

FIG. 33 shows the distal end of the control device 1078 being removablyconnected to the valve 1000. Specifically, the connection member 1078(yoke) is shown in contact with the drum 1045. The tethers 1075 areshown extending from the control catheter 1071 and looping through oraround each side or arm of the connection member 1078 and acorresponding loop 1039 of the attachment member 1038. The loopedarrangement of the tethers 1075 through and/or around the connectionmember 1078 and the attachment member 1038 of the valve 1000 is suchthat each of the proximal end and the distal end of the tether 1075extends through and outside of (e.g., proximal to) a single control arm1077 of the control portion 1072. As such, a proximally directed forcecan be exerted on each of the proximal end and the distal end of thetether(s) 1075 to increase a tension along the tether 1075, which pullsthe connection member 1038 toward the drum 1045, thereby securing theconnection member 1078 to the valve. Conversely, a proximally directedforce exerted on only one of the proximal end or the distal end of thetether(s) 1075 can disengage the tether(s) 1075 from the connectionmember 1078 and can withdraw the tether(s) 1075 from the control device1070, which in turn, can allow the connection member 1078 to bedecoupled or removed from the valve 1000.

FIG. 33 further shows a tension member 1076 extending from the controlcatheter 1071 (e.g., through one of the tether or tension member lumens1073) and through the waypoint 1028. The tension member 1076 can be, forexample, an actuator or the like that can selectively engage a proximalanchoring element 1034 formed by the subannular region 1030 of the valve1000. The tension member 1076 can be routed through one of the controlarms 1077 of the control portion 1072, one of the lumens 1073corresponding to that control arm 1077, around and/or through one ormore portions of the proximal anchoring element 1034, and back throughthe corresponding lumen 1073. As such, the tension member 1076 can beactuated (or placed in tension) and/or release in a manner similar tothat described above with reference to the tethers 1075. Moreover,increasing an amount of tension along the tension member 1076 can beoperable to transition the proximal anchoring element 1034 between afirst configuration and a second configuration, as described in detailabove with reference to the valves 600 and/or 700.

FIG. 33 further shows the guidewire catheter 1084 extending from thecontrol catheter 1071 (e.g., through the guidewire catheter lumen 1074)and through the waypoint 1028. The valve 1000 is shown with thesubannular member 1030 having and/or forming a distal anchoring element1032 having a guidewire coupler 1033 that can receive the guidewirecatheter 1084 through an opening, hole, aperture, port, etc., defined bythe guidewire coupler 1033. Thus, the guidewire catheter 1084 is shownextending from the control catheter 1071 (in a supra-annular positionrelative to the valve 1000), through the waypoint 1028 of the valve1000, below the flow control component 1050, and through the distalsubannular anchoring element 1032. Moreover, the guidewire catheter 1084is shown extending beyond the distal anchoring element 1032 and can haveand/or can provide sufficient stiffness to allow the valve 1000 beadvanced along a guidewire 1085 over which the guidewire catheter 1084is disposed. The arrangement of the control device 1072 just describedallows the control device 1072, including the connection member 1078,the tethers 1075, the tension member 1076, and the guidewire catheter1084, to be decoupled from the valve 1000 and withdrawn through thedelivery catheter 1082 after successful deployment of the valve 1000.

FIGS. 34A and 34B show the distal end of the control device 1070 in afirst configuration and a second configuration, respectively. The distalend of the control device 1070 is removably coupled to the valve 1000 asdescribed above. FIG. 34A shows the distal end of the control catheter1071 having a substantially straight or undeformed shape when in thefirst configuration. FIG. 34B shows the distal end of the controlcatheter 1071 in a second configuration in which the distal end is bent,flexed, steered, curved, deflected, deformed, and/or the like. Forexample, as described above, the tethers 1075 can be looped through theattachment member 1038 to removably couple the connection member 1078 tothe supra-annular region 1020 of the valve 1000 while the tension member1076 can be looped around and/or through one or more portions of theproximal subannular anchoring element 1034. In some instances, a tensionalong the tension member 1076 can be increased to transition theproximal anchoring element 1034 between the first configuration and thesecond configuration. In some instances, the tension along the tethers1075 and the tension along the tension member 1076 can be at leastpartially opposing forces exerted on a relatively small portion of thevalve 1000 and while the valve 1000 has a somewhat limited range ofmotion (e.g., due to the guidewire catheter 1084, as described above).As such, a tension along the tension member 1076 that exceeds athreshold amount of tension can be operable to bend, flex, steer, curve,deflect, and/or otherwise deform the distal end of the control catheter1071. In other words, increasing a tension along the tension member 1076can, in some instances, allow for a steering and/or otherwise desireddeflection of the control catheter 1071. In some instances, for example,the control catheter 1071 can be deflected and/or bent in asupra-annular direction relative to the valve 1000 such that a distallydirected force along the control catheter 1071 results in the connectionmember 1078 exerting a force on the valve 1000 that is at leastpartially in a subannular direction, thereby facilitating a deploymentand/or seating of the valve 1000 in the native annulus.

FIGS. 35-39 are cross-sectional views of the delivery system 1080showing a process of placing the valve 1000 in the deliveryconfiguration and loading the valve 1000 into the delivery device 1081for side-delivery into the heart. Prior to loading the valve 1000 (or inan at least partially concurrent process), a user, operator, surgeon,etc., can manipulate the delivery device 1081 to advance the guidewire1085 along a pathway through the patient and into a desired positionwith the heart. In some instances, the dilator 1058 can be advancedalong the guidewire 1085 and manipulated to dilate at least a portion ofthe pathway through the patient. The delivery catheter 1082 can then beadvanced through the pathway to place the distal end of the deliverycatheter 1082 in a volume of the heart (e.g., an atrium). Moreover, thearrangement of the delivery device 1081 is such that a proximal end ofthe guidewire 1085 extends from a proximal end of the handle 1088 of thedelivery device 1081, as described in further detail herein.

FIG. 35 shows the compression device 1090 removably coupled to theproximal end of the loading device 1060 and the distal end of theloading device 1060 removably coupled to the pulling device 1098. Morespecifically, the tether 1099 of the pulling device 1098 can extendthrough the lumen 1063 of the loading device 1060 and the lumen 1095 ofthe compression device and can be removably coupled to the distal end ofthe valve 1000 (e.g., looped around or through one or more portions ofthe distal end of the valve 1000). The ends of the tether 1099 are showndisposed about and/or at least partially wrapped around a spool or thelike of the pulling device 1098. In this embodiment, rotation of thespool or portion of the pulling device 1098 increases a tension alongthe tether 1099, which is operable to pull the valve 1000 through thecompression device 1090 and/or the loading device 1060. Moreover, duringa loading of the valve 1000 into the loading device 1060, the gate 1066is in the close state and thus, the tether 1099 can be configured toextend through a space defined between the gate 1066 and an innersurface of the loading device 1060 (as described above).

FIG. 35 shows the distal end of the valve 1000 removably coupled to thetether 1099 of the pulling device 1098 and the proximal end of the valve1000 removably coupled to the control device 1070. The guidewirecatheter 1084 is shown as extending through the valve 1000 and distal tothe distal subannular anchoring element. FIG. 35 further shows the valve1000 partially inserted into the lumen 1095 of the compression device1090. As described above, the valve 1000 can be at least partiallycompressed in the later direction prior to inserting the valve 1000 intothe compression device 1090. Thus, the valve 1000 is shown beinglaterally compressed but not yet axially compressed (substantially). Asdescribed above, in some instances, the valve 1000 can be loaded intothe compression device 1090 and advanced through the lumen 1095 while atleast the compression device 1090 is disposed in a saline bath or thelike, which can facilitate the advancement of the valve 1000 through thecompression device 1090 and can maintain a substantial sterility of thevalve 1000.

FIG. 36 shows the valve 1000 at least partially advanced through thecompression device 1090 and into the lumen 1063 of the loading device1060. For example, after initially inserting the valve 1000 into theproximal end of the compression device 1090 a user or operator can, forexample, manipulate the pulling device 1098 to further spool and/or wrapthe tether 1099. In some implementations, a user and/or operator canalso exert a force on the control device 1070 such that the connectionmember (not shown) pushes the valve 1000 through the compression device1090. The valve 1000 is shown as being advanced through the lumen 1095of the compression device 1090 from the proximal end to the distal endand the compression device 1090 compresses the valve 1000 in at leastthe axial direction as the valve 1000 is advanced therethrough. In someinstance, the valve 1000 can be in a substantially uncompressed or alaterally compressed configuration when inserted into the proximal endof the compression device 1090 and can be compressed to a compressed ordelivery configuration when advanced to and/or through the distal end ofthe compression device 1090 and into the lumen 1063 of the loadingdevice 1060 (FIG. 36).

FIGS. 35-37 show that the valve 1000 is loaded into the loading device1060 while the gate 1066 is in the closed state. FIG. 37 shows the valve1000 advanced through the lumen 1063 until, for example, the distalanchoring element (or a distal most portion) of the valve 1000 contactsand/or is adjacent to a proximal surface of the gate 1066 in the closedstate. The guidewire catheter 1084 extends distally from the valve 1000,through the gate 1066 in the closed state, and beyond the distal end ofthe loading device 1060. In some embodiments, for example, the gate 1066can have a shape and/or size such that a space is defined between anedge of the gate 1066 and an inner surface of the loading device 1060allowing the guidewire catheter 1084 and the tether 1099 of the pullingdevice 1098 to extend therethrough. In some embodiments, the gate 1066can define an opening, a hole, a notch, a recess, and/or the likethrough which the guidewire catheter 1084 and the tether 1099 canextend.

After advancing the valve 1000 into the loading device 1060, thecompression device 1090 can be removed from the proximal end of theloading device 1060. As described above, the first member 1091 andsecond member 1092 of the compression device 1090 are laterallyseparable when the coupler 1093 is removed. Thus, the coupler 1093 canbe removed and the first member 1091 and the second member 1092 can beseparated to decouple the compression device 1090 from the proximal endof the loading device 1060 without, for example, disconnecting,removing, and/or substantially changing the control device 1070 relativeto the valve 1000. After removing the compression device 1090 from theloading device 1060, a hemostasis valve 1068 and/or the like can beadvanced over a portion of the control device 1070 and coupled to theproximal end of the loading device 1060 (see e.g., FIG. 38). Thehemostasis valve 1068 a form a substantially fluid tight seal at theproximal end of the loading device 1060 (e.g., and around the controldevice 1070 and/or a control catheter thereof). Moreover, the pullingdevice 1098 can also be decoupled and/or removed from the distal end ofthe loading device 1060 and the tether 1098 can be decoupled from thevalve 1000 and withdrawn from the loading device 1060.

With the hemostasis valve 1068 coupled to the proximal end of theloading device 1060 and the distal end of the loading device 1060decoupled from the loading device 1060, the loading device 1060 is readyfor coupling to the delivery device 1081. Thus, with the valve 1000being loaded into the loading device 1060 while in the fluid (e.g.,saline) bath, the loading device 1060 with the valve 1000 in thedelivery configuration disposed in the lumen 1063, the hemostasis valve1068 coupled to the proximal end, and the gate 1066 in the closed statecan be removed from the bath and brought to, for example, an operatingtable or the like to be coupled to the proximal end of the deliverydevice 1081 that is already inserted into the patient.

FIG. 38 show the distal end of the loading device 1060 coupled to theproximal end of the delivery device 1081. FIG. 39 is an enlarged view ofa portion of the delivery system 1080 and shows the indexing feature1089 of the handle 1088 engaging an indexing feature 1069 included inthe distal end portion of the loading device 1069. The indexing features1089 and 1069 are show having a key-and-slot arrangement, though othermodes of indexing are possible. The indexing features 1089 and 1069ensure that the delivery device 1081 is in a predetermined and/ordesired orientation relative to the loading device 1060, and as such,the valve 1000 can be transferred into the delivery device 1000 in apredetermined and/or desired orientation (e.g., set and/or defined, forexample, by the way the valve 1000 is inserted into the lumen 1095 ofthe compression device 1090—according to the perimeter of the lumen 1095at the proximal end of the compression member 1090).

As described above, the delivery catheter 1082 is previous inserted intothe patient and the proximal end of the guidewire 1085 extends from theproximal end of the handle 1088 of the delivery device 1081.Accordingly, prior to coupling the distal end of the loading device 1060to the proximal end of the handle 1088, the proximal end of theguidewire 1085 is inserted into the guidewire catheter 1084. Asdescribed above, the loading device 1060 is coupled to the proximal endof the handle 1088 while the valve 1000 is proximal to the gate 1066 ofthe loading device 1060 and each of the gates 1066 and 1086 of theloading device 1060 and the delivery device 1081, respectively, is in aclosed state. In some implementations, after coupling the loading device1060 to the delivery device 1081 and before transitioning the gates 1066and 1086 to the open state, the volume collectively defined by thelumens 1063 and 1083 disposed between the gates 1066 and 1086 can beflushed via the ports 1067 and 1087. For example, in someimplementations, the port(s) 1087 can provide a flow of saline and/orother sterile fluid into the volume while the port(s) 1067 can provide asuction to and/or through at least the volume (or vice versa).

FIGS. 38 and 39 show that after coupling the loading device 1060 to thehandle 1088 of the delivery device 1081 and after flushing the volumedefined between the gates 1066 and 1086, the gates 1066 and 1086 can betransitioned from the closed state to the open state. As such, thelumens 1063 and 1083 are substantially open or otherwise not occluded.Thus, a user and/or operator can exert a distal force on, for example,the control portion 1072 of the control device 1070 to advance the valve1000 in the delivery configuration from the loading device 1060 and intothe lumen 1083 of the delivery device 1081 and through the deliverycatheter 1082. The valve 1000 can then be at least partially releasedfrom distal end delivery catheter 1082 and once released (or at leastpartially released), the control device 1070 can control and/ormanipulate the valve 1000 to seat the valve in the annulus of the nativeheart valve (e.g., as described above with reference to FIGS. 29-34B).

In some instances, it may be desirable to at least partially retrievethe valve 1000 from the annulus during deployment (e.g., to adjust aposition, orientation, and/or seating of the valve 1000 in the annulus).In such instances, the control device 1070 further can be used to atleast partially retrieve the valve 1000 into the distal end of thedelivery catheter 1082. For example, with the connection member 1078(yoke) removably coupled to the valve 1000, the user and/or operator canexert a proximally directed force on the control device 1070 that canpull that valve 1000 proximally toward and/or into the delivery catheter1082. Moreover, the delivery system 1080 can include any suitablecapture element, feature, member, mechanism, etc. (such as thosedescribed herein with reference to specific embodiments) configured tofacilitate a compression of the valve 1000 as the valve 1000 is pulledin a proximal direction toward and/or into the delivery catheter 1082.In some instances, after partially retrieving the valve 1000, thecontrol device 1070 can be manipulated to reseat the valve 1000 in theannulus in a desired orientation and/or configuration.

FIG. 40 is an illustration of a top perspective view of a valve 1100with a guidewire 1185 threaded through a waypoint 1128 and a positioningand/or control catheter 1171 attached on a proximal side of the valve1100. A delivery catheter 1182 is shown having the guidewire 1185 andthe positioning and/or control catheter 1171 disposed within a lumen ofthe delivery catheter 1182.

FIG. 41 is an illustration of a side perspective view of a valve 1200with a guidewire 1285 threaded through a waypoint 1228 and a positioningand/or control catheter 1271 is attached on a proximal side of the valve1200. A delivery catheter 1282 is shown having the guidewire 1285 andthe positioning and/or control catheter 1271 disposed within a lumen ofthe delivery catheter 1282.

FIG. 42 is an illustration of a below perspective view of a valve 1300being coupled to a positioning and/or control catheter 1371. A catheterguide and/or support can provide additional connection and support ofthe positioning and/or control catheter 1371 during attachment with thevalve 1300. A mount 1335 is shown for attaching the positioning and/orcontrol catheter 1371 to the valve 1300. In some embodiments, thepositioning and/or control catheter 1371 has a threaded portion thatengages a matching threaded component on the valve 1300, whereby thepositioning and/or control catheter 1371 can be rotated toengage/disengage the positioning and/or control catheter 1371 from thevalve 1300. A distal anchor channel and proximal anchor channel can beincluded and/or formed by an outside portion of a sidewall 1312 of thevalve 1300 and provide, for example, subannular access from a collarportion 1320 through the channel, to the subannular space for deployinga tissue anchor (not shown). A distal anchoring element 1332 and aguidewire coupler or anchor head 1333 are shown extending distally fromthe lower portion or subannular region 1320 of the valve 1300.

FIG. 43 is an illustration of a side perspective view of components of adelivery system 1480. A loading device 1460 with a loading compressioncylinder 1462 are shown in one component. A delivery device 1481 andthreaded mount 1435 are shown in a second component. A guidewire 1485and a positioning and/or control catheter 1471 are shown threadedthrough a receiver at a proximal end of a delivery catheter 1482. Thepositioning and/or control catheter 1471 can be equipped with a luerlock and/or the like to provide a port 1487 for flushing liquid throughthe lumen of the positioning and/or control catheter 1471 and/or thedeliver catheter 1482.

FIG. 44 is an illustration of a side perspective view of the valve 1400starting a compression process associated with loading the valve 1400into the loading device 1460. A distal anchoring element 1432 is shownleading the valve 1400 into the loading compression cylinder 1462. Acollar or supra-annular region 1420 of the valve 1400 is shown withlateral portions starting to fold downward and/or inward to lay flatagainst the sidewall of the valve 1400.

FIG. 45 is an illustration of a side perspective view of the valve 1400partially inserted into the loading compression cylinder 1462. The valve1400 is further compressed as the valve 1400 is inserted into theloading device 1460. FIG. 45 shows the valve 1400 nearly completelyloaded into the loading compression cylinder 1462. The guidewire 1485and the positioning and/or control catheter 1471 are shown attached tothe valve 1400 as it is compressed.

FIG. 46 is an illustration of a side perspective view of the loadingdevice 1460 connected to the delivery device 1481. The valve 1400 isshown fully compressed into a compressed or delivery configurationwithin the loading compression cylinder 1462. The connection of theloading device 1460 to the delivery device 1481 allows the valve 1400 tobe advanced from the loading device 1460 and through the deliverycatheter 1482 for deployment in the patient.

FIG. 47A is an illustration of a side view of compression device 1590with a loading device 1560 (e.g., a compression or receiver catheter)located at a distal end and a tether 1599 attached to a side-deliveredvalve 1500, according to an embodiment. FIG. 47A shows the valve 1500having a distal tether ring 1511 that is adjacent a distal anchoringelement 1532. The compression device 1590 defines a lumen, volume,space, and/or the like that has and/or forms a rectangular cavity 1595A(e.g., at a proximal end), which leads to transition cavity 1595B, whichleads to circular cavity 1595C (e.g., at a distal end and adjacent theloading device 1560).

FIG. 47B is an illustration of a side view of the valve 1500 beingpulled by the tether 1599 right to left into the rectangular cavity1595A of the compression device 1590, towards the transition cavity1595B. The loading device 1560 is connected to the compression device1590 at a distal end (e.g., adjacent the circular cavity 1595C). Thisconnection can be a threaded connection, a tension/form-fittingconnection, or other type of connection such as bead-and-channel, or aclamp-on connection. FIG. 47C is an illustration of a side view of thevalve 1500 being pulled further right to left from the rectangularcavity 1595A, through the transition cavity 1595B, and into the circularcavity 1595C of the compression device 1590. The distal anchoringelement 1532 is shown as leading the valve 1500 into a lumen of theloading device 1560.

FIG. 47D is an illustration of a side view of the valve 1500 beingpulled by the tether 1599 right to left out of the compression device1590 and into the lumen of the loading device 1560 coupled to thecompression device 1590 at the distal end (e.g., adjacent the circularcavity 1595C). FIG. 47E is an illustration of a side view of the valve1500 in a compressed and/or delivery configuration entirely disposedwithin the loading device 1560. The loading device 1560 is showndecoupled and/or otherwise removed from the compression device 1590.

FIG. 47F is an illustration of a side view of a pushing device 1519engaging the valve 1500 in the compressed configuration within theloading device 1560. Moreover, the loading device 1560 is shownconnected to a delivery catheter 1582. The pushing device 1519 caninclude a screw mechanism or the like, which can be used to advance apush rod 1519A to push the compressed valve 1500. The push rod 1519A isshown with a distal end 1519B that engages a sidewall of the valve 1500to advance and/or push the valve 1500 in the delivery configuration fromthe loading device 1560 to the delivery catheter 1582. Once the valve1500 in the delivery configuration is disposed in the delivery catheter1582, the distal anchoring element 1532 can be pointed toward a distalopen end of the delivery catheter 1582 through which the valve 1500 wasjust advanced. FIG. 47G is an illustration of a side view of the valve1500 in the delivery configuration disposed in a lumen of the deliverycatheter 1582 via the pushing device 1519. The valve 1500 is shownsuccessfully loaded into the delivery catheter 1582, and the loadingdevice 1560 can be disengaged from the valve 1500 and withdrawn from thedelivery catheter 1582. Thus, the valve 1500 is ready for side-deliveryinto a native annulus via the delivery catheter 1582.

FIG. 48A is an illustration of a side view of compression device 1690with a loading device 1660 located at a distal end of the compressiondevice 1690 and with a tether 1699 attached to a distal end of aside-deliverable valve 1600 having a guidewire 1685 and a torque and/orpositioning cable 1647 attached to a proximal end of the valve 1600.FIG. 48A shows the valve 1600 having a distal tether ring 1611 that isadjacent a distal anchoring element 1632. The compression device 1690defines a lumen, volume, space, and/or the like that has and/or forms arectangular cavity 1695A (e.g., at a proximal end), which leads totransition cavity 1695B, which leads to circular cavity 1695C (e.g., ata distal end and adjacent the loading device 1660).

FIG. 48A shows an embodiment of the compression device 1690 that has atwo-part or otherwise multi-part construction. For example, thecompression device 1690 can include two, substantially mirrored partsthat can be laterally separable or disassembled and removed withoutdisconnecting wires, cables, tethers, catheters, etc. from the valve1600. The valve 1600 includes a waypoint 1628 for running the guidewire1685 through a supra-annular region 1620 (e.g., a collar, drum, etc.)and through the distal subannular anchoring element 1632. The torqueand/or positioning cable 1647 is attached to the valve 1600 using athreaded receiver 1635 that can be remotely disconnected by axiallyrotating the torque and/or positioning cable 1647.

FIG. 48B is an illustration of a side view of the valve 1600 (and theguidewire 1685 and the torque and/or positioning catheter 1647 attachedthereto) being pulled by the tether 1699 right to left into therectangular cavity 1695A of the compression device 1690 and towards thetransition cavity 1695B. The loading device 1660 is shown connected to adistal end of the compression device 1690. This connection can be athreaded connection, a tension/form-fitting connection, or other type ofconnection such as bead-and-channel, or a clamp-on connection. FIG. 48Cis an illustration of a side view of the valve 1600, the guidewire 1685,and the cable 1647 being pulled further right to left through thetransition cavity 1695B and into the circular cavity 1695C of thecompression device 1690. The distal anchoring element 1632 is shownleading the valve 1600 into a lumen of the loading device 1660.

FIG. 48D is an illustration of a side view of the valve 1600, theguidewire 1685, and the cable 1647 pulled by the tether 1699 right toleft out of the compression device 1690 and into the loading device 1660coupled to the compression device 1690 at the distal end. FIG. 48E is anillustration of a side view of the valve 1600 in a compressed and/ordelivery configuration entirely disposed within the loading device 1660and having the guidewire 1685 and the cable 1647 coupled thereto. Thecompression device 1690 is shown as being laterally separated into firstpart 1691 and a second part 1692 allowing the compression device 1690 tobe removed from the loading device 1660 while maintaining connection ofthe valve 1600 to the pre-attached guidewire 1685 and cable 1647.

FIG. 48F is an illustration of a side view of the valve 1600 in thedelivery configuration, and with the guidewire 1685 and cable 1647attached, disposed within the loading device 1660 and the loading device1660 connected, coupled, and/or inserted into the delivery catheter1682. FIG. 48G is an illustration of a side view of a pushing device1619 after engaging the valve 1600 within the loading device 1660 topush the compressed valve 1600 from the loading device 1660 to adelivery catheter 1682, according to the invention. The pushing device1619 can include a screw mechanism 1619B, which can be used to advance apush rod 1619 to push the compressed valve 1600. The push rod 1619 isshown with a distal end 1619A that engages a sidewall of the valve 1600to advance and/or push the valve 1600 in the delivery configuration fromthe loading device 1660 to the delivery catheter 1682. The valve 1600 isadvanced from the loading device 1660 (in which the valve 1600 isdisposed with the distal anchoring element 1632 facing an oppositedirection from that used during an anchor-first delivery to theatrioventricular valve) to the delivery catheter 1682 to correct theorientation of the valve 1600 and the distal anchoring element 1632.Once the valve 1600 in the delivery configuration is disposed in thedelivery catheter 1682, the distal anchoring element 1632 can be pointedtoward a distal open end of the delivery catheter 1682 through which thevalve 1600 was just advanced. FIG. 48G shows the valve 1600 successfullyloaded into the delivery catheter 1682, and the loading device 1660 isshown as being disengaged from the valve 1600 and withdrawn from thedelivery catheter 1682. Thus, the valve 1600 is ready for side-deliveryinto a native annulus via the delivery catheter 1682.

FIG. 49A is an illustration of a perspective view of a compressiondevice 1790 receiving a valve 1700, proximal side first, with a valvetether ring 1711 attached to a tether 1799. FIG. 49A shows a coupler1793 holding two halves of the compression device 1790 together, withthe coupler 1793 seated on a funnel neck element and abutting a shoulderelement 1796. FIG. 49A shows a portion of a lumen extending through thecompression device the defines and/or forms a rectangular cavity 1795Aat a proximal end of the compression device 1790. In some embodiments,the rectangular cavity 1795A can be sized and/or shaped to receive thevalve 1700 in an uncompressed configuration. In other embodiments, therectangular cavity 1795A can be size and/or shaped to receive the valve1700 at least partially in a laterally compressed or foldedconfiguration and an axially uncompressed configuration. In still otherembodiments, the rectangular cavity 1795A can be sized and/or shaped toreceive the valve 1700 at least partially in a laterally compressed andat least partially in an axially compressed configuration.

FIG. 49B is an illustration of a side cross-sectional view of the valve1700 being pulled into the compression device 1790, proximal side first,with a distal anchoring element 1732 trailing the valve 1700 through thecompression device 1790. A delivery catheter 1782 is shown connected toa distal end of the compression device 1790 (e.g., at or adjacent to acircular cavity 1795C portion of the lumen) and ready to receive thevalve 1700 in a delivery configuration from the compression device 1790.

FIG. 49C is an illustration of a side cross-sectional view of the valve1700 in the compressed or delivery configuration that has been pulleddirectly into the delivery catheter 1782 with the distal anchoringelement 1732 in a desired position (e.g., a distal position and/orotherwise oriented towards a distal end of delivery catheter), withoutusing a pushing device and/or the like otherwise associated with usingthe compression device 1790 to compress the valve 1700 to the deliveryconfiguration via a distal-anchor-first approach. Although not shown,this process of compressing and loading the valve 1700 can be used witha guidewire and a torque and/or positioning catheter pre-attached to thevalve 1700 (e.g., as described above with reference to FIGS. 48A-48G).

FIGS. 50A-50E are proximal end views of a prosthetic valve 1800 andillustrate a process of compressing the valve 1800 from an expanded oruncompressed configuration to a compressed and/or deliveryconfiguration, according to an embodiment. FIG. 50A shows the valve 1800in an uncompressed configuration. As shown, the valve 1800 has asupra-annular region (or collar portion) 1820 and a sidewall portion1812 (or transannular region). FIG. 50B shows the valve 1800 partiallycompressed with sides of the collar 1820 being folded down parallel withthe sidewall portion 1812. FIG. 50C shows the valve 1800 furthercompressed with the sides of the collar 1820 folded down and thesidewall portion 1812 folding inward. FIG. 50D shows the valve 1800further compressed with the sides of the collar 1820 folded down and thesidewall portion 1812 folding further inward. FIG. 50E shows the valve1800 further compressed with the sides of the collar 1820 folded down,the sidewall portion 1812 folded completely inward, and an axial heightof the valve 1800 compressed to place the valve 1800 in the deliveryconfiguration. FIG. 50F is an illustration of a cross-section of adelivery catheter 1882 showing how the compressed valve 1800 can fitwithin an inner diameter of the delivery catheter 1882.

FIGS. 51A and 51B illustrate a compressed valve 1900 disposed within ashuttle, loading, and/or valve catheter 1962, which is used to shuttlethe compressed valve 1900 within a larger outer delivery catheter 1982,in a tube-in-a-tube arrangement, according to an embodiment. FIG. 51Ashows the compressed valve 1900 within the shuttle catheter 1962, whichin turn, is being loaded and/or inserted into the delivery catheter1982. FIG. 51B shows the compressed valve 1900 partially disposed withinthe shuttle catheter 1962, which is partially disposed within thedelivery catheter 1982 during deployment of the valve 1900 into thenative annulus. The valve 1900 is shown partially released from theshuttle catheter 1962 with a distal anchoring element 1932 extending tothe native annulus while a remaining portion of the valve 1900 isdisposed in the shuttle catheter 1962.

As described above, any of the prosthetic valves described herein can bedelivered via a delivery system and can be configured to engage with thedelivery system in any suitable manner. In some implementations, aprosthetic valve can be configured to engage a delivery system in amanner similar to those described in the '010 PCT, the '108 PCT, the'327 Provisional, the '964 Provisional, the '345 Provisional, and/or the'807 Provisional incorporated by reference hereinabove.

For example, FIGS. 52A-52C illustrate side perspective views of a sidedelivered transcatheter prosthetic heart valve 2000 and an actuator 2070according to an embodiment. The valve 2000 has a frame 2010 with acollar 2020 (e.g., a supra-annular member), a distal anchoring element2032, and a proximal anchoring element 2034 (e.g., wire loop anchoringelements and/or any other suitable type of anchoring element). The frame2010 defines a waypoint 2028. The collar 2020 includes and/or forms anattachment point 2029. While the waypoint 2028 is shown along a body ofthe frame 2010, in other embodiments, the collar 2020 and/or any othersuitable portion of the valve 2000 can form and/or define the waypoint2028. Similarly, while the attachment point 2029 is shown along thecollar 2020, in other embodiments, the body of the frame 2010 and/or anyother suitable portion of the valve 2000 can include the attachmentpoint 2029.

In the embodiment shown in FIGS. 52A-52C, the actuator 2070 is arrangedas a tensile member and/or the like. The actuator 2070 includes a lead2041 configured to be coupled to and/or threaded through an attachmentpoint 2036 of the proximal anchoring element 2034. The lead 2041includes a first end that has and/or forms a first coupling feature 2044and a second end that has and/or forms a second coupling feature 2044.The coupling features can be any suitable configuration. For example, inthis embodiment, the first coupling feature 2044 is and/or forms a loop,eyelet, opening, and/or the like, and the second coupling feature 2042is and/or forms a ball, protrusion, knob, knot, and/or the like. Theactuator 2070 can be and/or can include any suitable cable, tether,wire, catheter, conduit, etc. In some implementations, the actuator 2070can be used, for example, as a pusher or the like configured to pushand/or otherwise advance the valve 2000 through a delivery system.

In this embodiment, the actuator 2070 includes a first cable 2047 withan end portion that forms a threaded coupler configured to engage and/orcouple to the attachment point 2029 formed by the collar (e.g., athreaded nut or the like). The actuator 2070 includes a second cable2048 with an end portion that forms a receiving member configured toreceive and/or removably couple to the second end of the lead 2041. Forexample, the receiving member of the second cable 2048 and the couplingfeature 2042 formed by the second end of the lead 2041 can be a ball andcup coupling mechanism. Moreover, the actuator 2070 can include and/orcan form an outer sheath or catheter configured to at least partiallyhouse the first cable 2047 and the second cable 2048.

FIG. 52A shows the actuator 2070 prior to coupling to the valve 2000and/or the lead 2041. The lead 2041 is shown threaded through a portionof the valve 2000 and the waypoint 2028, looped around or through theattachment point 2036 of the proximal anchoring element 2034, andthreaded back through the waypoint 2028 and portion of the valve 2000such that the first end 2044 and the second end 2042 are each outside ofthe valve 2000 and/or above or proximal to the collar 2020.

FIG. 52B shows, the end portion of the first cable 2047 of the actuator2070 coupled to the attachment point 2029 of the collar 2020, forexample, via a threaded coupling. The first coupling feature 2044 of thelead 2041 is coupled to the first cable 2047 (e.g., the first couplingfeature 2044 can be a loop that is disposed on or about the first cable2047). In some implementations, the actuator 2070 can be used as aproximal pusher by virtue of the first cable 2047 being coupled to theattachment point 2029 formed by the collar 2020. For example, asubstantially fixed portion of the first cable 2047 can extend from theactuator 2070 (e.g., the outer sheath) such that a distal or pushingforce applied to the actuator 2070, via the first cable 2047, pushes thevalve 2000. With the first coupling feature 2044 coupled to the firstcable 2047, the first end of the lead 2041 is maintained in a relativelyfixed position relative to the valve 2000. The second cable 2048 of theactuator 2070 is shown coupled to the second coupling feature 2042 ofthe lead 2041 (e.g., via a ball and cup coupling mechanism and/or thelike). Thus, while the actuator 2070 and/or the first cable 2047 can beused to push the valve 2000, a tensile or pulling force can be appliedto the second cable 2048, which can pull the second end of the lead 2041in a proximal direction, thereby placing the lead in tension.Accordingly, the lead 2041 can maintain the proximal anchoring element2034 in its first configuration during deployment.

FIG. 52C shows the first cable 2047 decoupled from the attachment point2029 of the collar 2020 and the first coupling feature 2044 at the firstend of the lead 2041. The second coupling feature 2042 at the second endof the lead 2041 can remain coupled to the second cable 2048. After thevalve has been deployed, the actuator 2070 is pulled to remove theactuator 2070 and the lead 2041 from the valve 2000 and the deliverysystem. With the actuator 2070 removed, the proximal anchoring element2034 is allowed to transition to its second configuration.

FIGS. 53A-53C are illustrations according to the invention of a seriesof three images showing a prosthetic valve 2100 being retrieved into adelivery/retrieval catheter 2182 where the longitudinal axis of thecatheter 2182 is not parallel to the central blood flow axis through thevalve 2100 like in traditional replacement valves, but insteadapproaches from the side (i.e., orthogonally) relative to theorientation of the blood flow through the valve 2100.

FIG. 53A shows a distal end portion of the delivery/retrieval catheter2182 accessing an atrium of the heart (e.g., via the inferior vena cavausing a transfemoral delivery and/or the like). FIG. 53B shows how anelongated connection member 2178 (e.g., a guidewire, a control push rod,a steerable catheter, a yoke, a tensile member, a suture, a tether, aretrieval tool, etc.) connects to a proximal side of the valve 2100(e.g., to a delivery system-valve attachment point, waypoint, connector,and/or the like). In some implementations, the elongated connectionmember 2178 is already attached to the valve 2100 (e.g., for delivery ofthe valve 2100 to the annulus.

In some implementations, a retrieval process (or a portion thereof) maybe performed during the initial valve deployment/delivery procedure andwhile the valve 2100 is still attached and/or connected to the elongatedconnection member 2178. For example, the retrieval process can beperformed to at least partially withdraw the prosthetic valve 2100 dueto a problem or medical issue identified by the interventionalist thatcalls for the valve 2100 that was being deployed, to be retrieved or atleast partially retrieved. In other implementations, a retrieval process(or a portion thereof) may be performed after the valve 2100 has beendeployed and disconnected from the elongated connection member 2178. Insuch implementations, the elongated connection member 2178 can bereconnected to the valve 2100 (or a new elongated connection member canbe connected to the valve 2100). In some implementations, attachmentand/or connection can be aided by the use of radio-markers on theelongated connection member 2178 and on a proximal portion of the valve2100.

FIG. 53C shows the valve 2100 pulled into the delivery/retrievalcatheter 2182. For example, the elongated connection member 2178 can beused to pull the proximal end of the valve 2100 into the distal endportion of the catheter 2182. In some implementations, the distal endportion of the catheter 2182 can be and/or can include a compression tipwith one or more features to assist compression and retraction of thevalve 2100, such as a surface coating, spiraled bead lines, spiraledchannels, and/or the like on the inner surface of the distal end portionof the catheter 2182 to assist compression and retraction of the valve2100 into the catheter 2100. As shown, the valve 2100 is folded andcompressed into the catheter 2182 with the elongated connection member2178 attached so that, in some instances, the delivery catheter 2182 canbe withdrawn and the valve 2100 retrieved from the patient.

FIGS. 54A to 541 are illustrations according to the invention of aseries of nine images showing a valve 2200 being retrieved from a nativeannulus model and into a delivery/retrieval catheter 2282 where thelongitudinal axis of the catheter 2282 is orthogonal to the orientationof the frame and flow control (valve leaflets) component of the valve2200.

FIG. 54A shows a distal end portion of the delivery/retrieval catheter2282 having an elongated connection member 2278 (e.g., a guidewire, acontrol push rod, a steerable catheter, a yoke, a tensile member, asuture, a tether, a retrieval tool, etc.) attached to a proximal portionof the prosthetic valve 2200. FIG. 54A shows a relatively large diametervalve (e.g., 65 mm×45 mm tubular frame (110 mm×72 mm including atrialcollar), with a 29 mm flow control component mounted within the tubularframe of the valve 2200) at least partially disposed in an openingcorresponding to and/or representing an annulus of a native heart valve.

FIG. 54B shows the prosthetic valve 2200 being drawn into thedelivery/retrieval catheter 2282 with about 10-20% of the valve 2200compressed within a lumen of the catheter 2282. FIG. 54B illustrates howthe prosthetic valve 2200 is designed to fold, front side approachingback side, and is designed to vertically compress, so that the largevalve becomes compressed within a standard sized transfemoral catheter(e.g., 22-32 Fr, or about a 28 Fr catheter). For sake of definition,French sizing can be converted to millimeter by dividing by 3, so that a22 Fr catheter has about an 8 mm inner diameter, a 30 Fr catheter hasabout a 10 mm inner diameter, and so forth.

FIG. 54C shows the prosthetic valve 2200 being drawn into thedelivery/retrieval catheter 2282 with about 20-30% of the valve 2200compressed within the lumen of the catheter 2282. FIG. 54C shows, forexample, a proximal anchoring location at least partially housed withinthe catheter 2282.

FIG. 54D shows the prosthetic valve 2200 being drawn into thedelivery/retrieval catheter 2282 with about 30-40% of the valve 2200compressed within the lumen of the catheter 2282. FIG. 54D shows, forexample, an atrial collar and/or supra-annular member of the valve framebeginning to fold inward toward a longitudinal axis (not shown).

FIGS. 54E and 54F show the prosthetic valve 2200 being drawn into thedelivery/retrieval catheter 2282 with about 50-60% of the valve 2200compressed within the lumen of the catheter 2282. FIGS. 54E and 54F showhow the valve 2200 has been at least partially withdrawn from theopening (annulus) and the valve 2200 has started to be verticallycompressed.

FIGS. 54G to 541 show the valve 2200 continuing to be drawn into thelumen of the delivery/retrieval catheter 2282 with about 70%, 80%, andover 90%, respectively, of the valve 2200 shown compressed within thelumen of the catheter 2282. FIGS. 54G to 541 show how the valve 2200continues to fold and/or compress and retract into thedelivery/retrieval catheter 2282.

FIGS. 55A-55D are schematic illustrations of a prosthetic valve 2300 andshow a process of retrieving the prosthetic valve into a delivery and/orretrieval catheter 2382, according to an embodiment. FIG. 55A is ananterior side view of the delivery and/or retrieval catheter 2382 havingan extended capture element 2308 encompassing a proximal end of thevalve 2300. A push/pull cable 2347 is shown extending through thedelivery catheter 2382 and attaching to the valve 2300. FIG. 55B is ananterior side view of the delivery and/or retrieval catheter 2382 havingthe extended capture element 2308 encompassing the proximal end of thevalve 2300, and the valve 2300 being compressed in height (y-axis) anddepth (z-axis) but not length (x-axis). FIG. 55C is an anterior sideview of the delivery and/or retrieval catheter 2382 having the extendedcapture element 2308 encompassing the proximal end of the valve 2300 andfacilitating further compression of the valve 2300 and capture/retrievalof the valve 2300 into a lumen of the delivery and/or retrieval catheter2382. FIG. 55D is an anterior side view of the delivery and/or retrievalcatheter 2382 having the capture element 2308 encompassing the proximalend of the valve 2300 and nearly completing the compression, capture,and retrieval of the valve 2300 into the lumen of the delivery and/orretrieval catheter 2382.

FIGS. 56A and 56B are schematic illustrations of a prosthetic valve 2400and distal end of a delivery and/or retrieval catheter 2482 having apush/pull cable 2447 attached to a proximal end of the valve 2400 and acompression mechanism and/or actuator 2470 to compress at least theproximal end of the valve 2400. For example, FIG. 56A shows acompression mechanism/actuator 2470 in the form of a suture(s),tether(s), cable(s), etc., configured to pull the proximal subannularanchoring element up against an underside of a supra-annular region ofthe valve 2400 (e.g., an underside of an atrial collar or the like).FIG. 56A shows the valve 2400 in a substantially uncompressedconfiguration. FIG. 56B shows the valve 2400 in a partially compressedconfiguration in response to a proximal force exerted on the compressionmechanism/actuator 2470 (e.g., the suture(s), tether(s), cable(s),etc.), where the proximal subannular anchoring element 2434 is pulled ina supra-annular direction toward the supra-annular region of the valve2400.

FIGS. 57A and 57B are schematic illustrations of a prosthetic valve 2500and distal end of a delivery and/or retrieval catheter 2582 having apush/pull cable 2547 attached to a proximal end of the valve 2500 and atleast one compression mechanism/actuator 2570 to compress at least theproximal end of the valve 2500. For example, FIG. 57A shows acompression mechanism/actuator 2570 in the form of a suture(s),tether(s), cable(s), etc., configured to pull the proximal subannularanchoring element 2534 up against an underside of a supra-annular regionof the valve 2500 (e.g., an underside of an atrial collar or the like)as well as a capture device 2508 loaded or pre-loaded within the lumenof the delivery and/or retrieval catheter 2582. The capture device 2508can be extended from the delivery and/or retrieval catheter 2582 toencompass at least a proximal end of the valve 2500.

FIG. 57A shows the valve 2500 in a substantially uncompressedconfiguration. FIG. 57B shows the valve 2500 in a partially compressedconfiguration in response to a proximal force exerted on the compressionmechanism (e.g., the suture(s), tether(s), cable(s), etc.), where theproximal subannular anchoring element is pulled in a supra-annulardirection toward the supra-annular region of the valve 2500. FIG. 57Bfurther shows the capture device extended from the delivery and/orretrieval catheter 2582 and encompassing at least the proximal end ofthe valve 2500. The capture device 2508 can facilitate a compression ofthe valve 2500 when a force exerted on the valve by the push/pull cable2547 pulls the valve 2500 toward the delivery and/or retrieval catheter2582.

FIGS. 58A and 58B are proximal end views of a prosthetic valve 2600 in afirst configuration and a second configuration, respectively, accordingto an embodiment. FIG. 58A shows a compression mechanism/actuator 2670such as, for example, one or more suture(s), tether(s), tensionmember(s), cable(s), filament(s), etc., coupled to a proximal side ofthe valve 2600. More particularly, the compression mechanism/actuator2670 can be routed around and/or through one or more proximal subannularsidewall portions, frame hips, anterior and/or posterior edges or wireframes, and/or any other suitable portion of the valve. In addition, thecompression mechanism/actuator 2670 or a second compression mechanismcan be coupled routed between and/or around a proximal anchoring element2634 and a supra-annular region or collar of the valve 2600. FIG. 58Ashows the proximal end of the valve 2600 in a substantially uncompressedor expanded configuration. FIG. 58B shows that the proximal anchoringelement 2634 and/or the proximal subannular sidewall portions can bedrawn inward and/or in a supra-annular direction toward thesupra-annular region or collar of the valve 2600 to place the valve 2600in the second configuration. The valve 2600 is shown at least partiallycompressed (or at least the proximal end of the valve 2600 is showncompressed) to allow for retrieval of the valve 2600 from a nativeannulus and, for example, into a lumen of a delivery and/or retrievalcatheter.

FIGS. 59A-59C are schematic illustrations of a prosthetic valve 2700 andshow a process of retrieving the prosthetic valve into a delivery and/orretrieval catheter 2782, according to an embodiment. FIG. 59A is ananterior side view of the delivery and/or retrieval catheter 2782 havingan extended capture element 2708 encompassing at least a proximal end ofthe valve 2700. The valve 2700 is shown at least partially compressed. Aproximal end portion of the valve 2700 is shown pulled and/or retrievedinto the delivery and/or retrieval catheter 2782. FIG. 59B shows thevalve 2700 further compressed and nearly fully retracted and/orretrieved into the lumen of the delivery and/or retrieval catheter 2782and the capture element 2708 and/or delivery and/or retrieval catheter2782 further compressing a mid-section and a distal portion of the valve2700 as the valve 2700 is drawn into the lumen of the delivery and/orretrieval catheter 2782. FIG. 59C shows the valve 2700 fully compressedand retracted and/or retrieved into the lumen of the delivery and/orretrieval catheter 2782.

FIG. 60A is an exploded side view illustration of a delivery and/orretrieval system 2880 having a capture element 2808 and delivery and/orretrieval catheter 2882 and being configured to deliver and/or retrievea valve 2800, according to an embodiment. FIG. 60B is a cross-sectionalside view of the delivery and/or retrieval system 2880 showing thecapture element 2808 integrated into a channel within the deliveryand/or retrieval catheter 2882 or using an outer and inner sheatheddelivery and/or retrieval catheter system with the capture element 2808disposed between the inner and the outer sheath. FIG. 60C is across-sectional side view of delivery and/or retrieval system 2880showing the capture element 2808 extended from the delivery and/orretrieval catheter 2882 after the valve 2800 has been deployed.

FIGS. 61A-61G are various views of a delivery and/or retrieval system2980 configured to deliver, deploy, and/or retrieve a prosthetic valve,according to an embodiment. FIG. 61A is a bottom view of a deliveryand/or retrieval catheter 2982 having a capture element 2908 extendingfrom a distal end of the catheter 2982 and encompassing at least aproximal end of the valve 2900. The capture element 2908 can be, forexample, a self-expanding wire mesh, basket, net, and/or the like. Insome embodiments, the capture element 2908 can be formed from ashape-memory alloy such as nitinol or the like. The capture element 2908can be in a compressed configuration and, in response to being advancedout of the distal end of the catheter 2982 can automatically transitionto an expanded configuration. In some implementations, the captureelement 2908 can be included in or on a sheath, a capture elementcatheter, a control catheter, and/or any other suitable tube, member,rod, catheter, etc. In some implementations, the capture element 2908can be disposed in the catheter 2982 during delivery of the valve 2900into a heart. In other implementations, the capture element 2908 can beinserted into and advanced through the delivery catheter 2982 duringdeployment of the valve 2900 when it is desirable to at least partiallyretrieve the valve 2900 from the native annulus and/or the heartentirely.

FIG. 61A is a bottom view showing the valve 2900 in a substantiallyuncompressed configuration with a push/pull cable 2947 attached to aproximal supra-annular portion of the valve 2900. The capture element2908 is shown extending from the catheter 2982 but not yet encompassingthe valve 2900. FIG. 61B is a bottom view showing the valve 2900 in apartially compressed configuration in which a proximal anchoring elementand/or proximal subannular sidewalls are pulled inward and/or upwardtoward the supra-annular region of the valve 2900. The capture element2908 is shown as beginning to extend over the proximal end of the valve2900. FIG. 61C is a bottom view showing the valve 2900 in a furthercompressed configuration in which the proximal anchoring element and/orproximal subannular sidewalls are further pulled inward and/or upward.The valve 2900 is shown as being pulled into the extended captureelement 2908 (e.g., in response to a force exerted by the push/pullcable 2947).

FIG. 61D is a septal-side view showing the proximal end of the valve2900 in a compressed configuration and pulled adjacent to the deliverycatheter 2982. The capture element 2908 is shown extending around and/orencompassing the proximal end of the valve 2900 to facilitate acompression of the valve 2900. FIG. 61E is a septal-side view showingthe proximal end of the valve 2900 at least partially disposed in thedelivery catheter 2982 and the capture element 2908 extending and/orencompassing more of the valve 2900 as the valve 2900 is pulled into thedelivery catheter 2982 (e.g., in response to a force exerted by thepush/pull cable 2947). The capture element 2908 is shown being pulledinto the catheter 2982 along with the valve 2900.

FIG. 61F is a septal-side view showing a mid-section of the valve 2900pulled into the delivery catheter 2982. The valve 2900 is furthercompressed as it is pulled into the delivery catheter 2982 and thecapture element 2908 is shown as encompassing a portion of the valve2900 distal to delivery catheter 2982 while also being pulled into thedelivery catheter 2982 with the valve 2900. FIG. 61G is a septal-sideview showing the valve 2900 in a substantially compressed configurationand nearly entirely pulled and/or retrieved into the catheter 2982.Although not shown, the capture element 2908 encompasses the portion ofthe valve 2900 disposed in the delivery catheter 2982. In someinstances, the compression of the valve 2900 can be sufficient to drawthe remaining portion of the valve 2900 into the catheter 2982substantially without the capture element 2908 facilitating acompression of the valve 2900.

FIGS. 62A-62B are top views of at least a portion of a delivery and/orretrieval system 3080 and showing a process of extending a captureelement 3008 around a proximal side of a prosthetic valve 3000 and aportion of a control device 3070 having a control catheter and a yoke3078 coupled to the proximal side of the prosthetic valve 3000,according to an embodiment. FIG. 62A shows the capture element 3008 as aself-expanding wire mesh that is extended from a delivery catheter (notshown) and over a portion of the control device 3070 while beingproximal to the valve 3000. The valve 3000 is shown having an offsetflow control component mounted to an outer frame. The outer frame has anupper atrial collar component (e.g., a supra-annular member or region)and a lower subannular component, member, and/or region. The yoke 3078is shown coupled to the upper atrial component. The valve 3000 and/orthe control catheter can further include an actuation and/or compressionsystem having one or more elements (e.g., sutures, tethers, tensionmembers, etc.) for raising, lowering, and/or compressing a proximalanchoring element of the valve 3000 and for pinching or compressing, forexample, subannular sidewall hips of the lower subannular component.FIG. 62B shows how the valve 3000 is brought within the funnel, mesh,basket, and/or structure of the capture element 3008, which guides thevalve 3000 toward and/or into the delivery catheter and facilitates acompression of the valve 3000 in a height dimension and in a widthdimension but not in a length dimension along a delivery axis.

FIGS. 63A-63E are various views of a portion of a delivery and/orretrieval system 3180 according to an embodiment. The delivery and/orretrieval system 3180 can be similar to any of the delivery and/orretrieval systems described above with reference to FIGS. 55A-62B, orcombinations thereof. The delivery and/or retrieval system 3180 isconfigured to deliver, deploy, and in some instances, retrieve aprosthetic valve 3100. The delivery and/or retrieval system 3180includes a delivery and/or retrieval catheter 3182, a control device3170 having a control catheter and a yoke 3178 mounted to a distal endof the control catheter, and a capture element 3108. In this embodiment,the delivery and/or retrieval system 3180 further includes an expansionelement 3109 configured to facilitate an expansion of the captureelement 3108 as the capture element 3108 extends from the deliverycatheter 3182 and about at least a portion of the valve 3100.

FIG. 63A is a perspective view of the expansion element 3109 included inthe delivery and/or retrieval system 3180. The expansion element 3109can be, for example, integrated into and/or a part of a distal endportion of the control catheter. In other embodiments, the expansionelement 3109 can be integrated into and/or a part of a separate sheath,catheter, tube, and/or element that can be advanced through the deliverycatheter 3182 (e.g., with or independent of the valve 3100). Theexpansion element 3109 is shown as an expandable frame, ramp, structure,and/or the like. The expansion element 3109 can be formed from, forexample, a shape-memory allow such as nitinol and/or the like. Theexpansion element 3109 can be collapsible, allowing the expansionelement 3109 to be advanced through the delivery catheter 3182, and canbe expandable when released from a distal end of the delivery catheter3182 (e.g., self-expanding, automatically expanding, and/or expanding inresponse to a force or other input).

FIG. 63B is a perspective side view of the valve 3100 and shows a distalend of the delivery catheter 3182 proximal to the valve 3100, the yoke3178 of the control device 3170 coupled to a supra-annular region 3120of the valve 3100, and a tension member and/or actuation mechanismextending through a waypoint of the valve 3100, for example, toselectively engage a proximal anchoring element 3132 of a subannularregion 3130 of the valve 3100. FIG. 63B shows the yoke 3178 removablysecured to attachment points along the supra-annular region 3120 of thevalve 3100. In some implementations, securement of the yoke 3178 to thesupra-annular region 3120 can allow a distal force exerted on thecontrol device to be transmitted, via the yoke 3178, to the valve 3100,which can be used during delivery and/or deployment of the valve 3100.Similarly, the securement of the yoke 3178 to the supra-annular region3120 can allow a proximal force exerted on the control device to betransmitted, via the yoke 3178, to the valve 3100, which can be usedduring retrieval of the valve 3100.

FIG. 63B further shows the expansion element 3109 in a distal positionrelative to the distal end of the delivery catheter 3182 (but in aproximal portion relative to the distal end of the control catheter).Moreover, the capture element 3108 is shown as being extended from thedelivery catheter 3182 in a distal direction. The coaxial arrangement ofthe delivery and/or retrieval system 3180 is such that the captureelement 3108 contacts at least a portion of the expansion element 3109as the capture element 3108 extends from the delivery catheter 3182,which in turn, causes the capture element 3108 to expand radiallyrelative to the common axis (e.g., a delivery axis). FIG. 63C shows thecapture element 3108 further extended from the delivery catheter 3182and shows that the arrangement of the expansion element 3109 preventsand/or reduces a likelihood of the capture element 3108 becomingentangled with the control device (e.g., the yoke 3178, the tensionmember, and/or any other suitable portion of the control device).

FIG. 63D shows the capture element 3108 in an extended configurationsuch that the capture element 3108 encompasses at least the proximal endof the valve 3100. FIG. 63E shows the valve 3100 being pulled in aproximal direction in response to a proximally directed force exerted onthe control device. The expansion element 3109 and the control catheterare retracted into the delivery catheter 3182 and thus, are not shown.The yoke 3178 is shown partially retracted into the delivery catheter3182. The valve 3100 is shown pulled toward the delivery catheter 3182and the proximal end of the valve 3100 is shown in a compressedconfiguration. The capture element 3108 encompassing at least theproximal end of the valve 3100 facilitates a compression of at least theproximal end. Moreover, the operator can manipulate a proximal end ofthe tension member (e.g., actuation mechanism) to transition theproximal end of the valve 3100 (or at least the proximal anchoringelement 3134) from an expanded configuration to a compressedconfiguration. Thus, as the valve 3100 is pulled in a proximal directiontoward the delivery catheter 3182, the control device and/or the captureelement 3108 act to compress the valve. Although not shown in FIG. 63E,with the proximal end of the valve 3100 sufficiently compressed, furtherforce in the proximal direction exerted by the control device can pullthe valve 3100 into the delivery and/or retrieval catheter 3182.

As described above with reference to the control catheter shown in FIGS.34A and 34B, any of the control catheters, delivery catheters, sheaths,tubes, etc., can be at least partially steerable and/or otherwiseselectively movable, bendable, deformable, and/or the like. In someinstances, a portion of an attachment device such as a yoke or the likeintegrated into a distal end of a control catheter can providestructural stiffness to the distal end of the control catheter allowingfor a desired deflection, bending, and/or deformation without, forexample, kinking, plastically (e.g., permanently) deforming, breaking,buckling, etc.

For example, FIGS. 64A and 64B are each a top view of a laser-cutworkpiece configured to be formed into at least a part of a distal endof a control device having, for example, a yoke, according to differentembodiments. FIG. 64A shows a laser-cut workpiece 3278A includingmultiple slots, slits, notches, cuts, and/or the like. Although shown asa flat pattern and/or otherwise as a flat sheet, the workpiece 3278A canbe, for example, a laser cut cylinder or the like. In other embodiments,the workpiece 3278A can be laser-cut and then heat-set and/or otherwiseformed into a substantially cylindrical shape with a yoke formed at adistal end thereof. In some implementations, the cylindrical workpiece3278A can be integrated into a distal end of the control catheter and/orthe like. In other implementations, the distal end of the controlcatheter can be over-molded and/or otherwise extruded over, around,and/or about a portion of the workpiece 3278A thereby forming anintegrated distal end. Moreover, the pattern of slots, slits, notches,cuts, and/or the like can be selected to result in a desired flexibilityand/or stiffness of the distal end of the control catheter and/or thelike. In some implementations, for example, the desired flexibilityand/or stiffness can allow a distal end of a control catheter to bend,flex, and/or deform in a manner similar to that shown in FIG. 34B.

FIG. 64B shows a laser-cut workpiece 3378A including multiple spiraledpatterns forming a set of dovetails or the like. As described above withreference to the workpiece 3278A shown in FIG. 64A, the workpiece 3378Acan be formed from a laser cut cylinder or can be formed from alaser-cut sheet that is subsequently heat-set and/or otherwise formedinto a substantially cylindrical shape and integrated into a distal endportion of a control catheter and/or the like.

FIG. 65 is a flowchart illustrating a method 10 of compressing aprosthetic valve into a delivery configuration for side-delivery to apatient via a delivery catheter, according to an embodiment. The valvecan be substantially similar to any of those described herein such asthe valves 100, 400, 500, 600, 700, 800, and/or 1000 and/or any of thosedescribed in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the'108 PCT, the '327 Provisional, the '964 Provisional, the '345Provisional, and/or the '807 Provisional incorporated by referenceherein. For example, the valve can include an outer support frame and an(inner) flow control component that is mounted in and/or to the outersupport frame. The outer support frame can include, for example, asupra-annular member or region, a subannular member or region, and atransannular member or region coupled therebetween. The flow controlcomponent is mounted to the outer support frame such that is extendsthrough a portion of the transannular member or region, as describedabove. Moreover, the valve is compressible along a central axis parallelto a fluid flow direction through the valve and a lateral axisorthogonal and/or perpendicular to the central axis.

The method 10 includes compressing the prosthetic valve along thelateral axis of the valve perpendicular to the central axis, at 11. Insome implementations, the valve is manually compressed along the lateralaxis. For example, a user can exert a lateral force on the valve tocompress, fold, and/or squeeze the valve into a laterally compressedconfiguration.

After laterally compressing the valve, the valve is inserted into aproximal end of a compression device that defines a lumen extendingthrough the proximal end and a distal end, at 12. In some embodiments, aperimeter of the lumen at the proximal end is larger than a perimeter ofthe lumen at the distal end as described above with reference to thecompression device 1090. Moreover, in some implementations, the valvecan be inserted into the compression device while that the compressiondevice and the valve are disposed in a fluid bath (e.g., a saline bathor the like). As described above, a distal end of the valve can beinserted into the compression device prior to a proximal end of thevalve (e.g., a distal anchoring element can lead the valve through thecompression device).

The prosthetic valve is advanced through the lumen of the compressiondevice to compress the prosthetic valve along the central axis, at 13.In some implementations, the advancing of the valve can be in responseto a control device and/or the like exerting a force on a proximal endof the valve to push the valve through the compression device, inresponse to a pulling device pulling the valve through the compressiondevice (e.g., via a tether or the like attached to a distal end of thevalve), or in response to a combination of pushing and/or pulling. Asdescribed above, a lumen of the compression device can be tapered in atleast the axial direction as the lumen extends from the proximal end tothe distal end of the compression device. The lumen at the distal end ofthe compression device can have a perimeter and/or diameter isassociated with, for example, an axial-lateral extent of the valve in acompressed and/or delivery configuration. In other words, advancing thevalve through the compression device places the valve in the deliveryconfiguration.

The prosthetic valve in the delivery configuration is transferred fromthe distal end of the compression device into a loading device coupledto the distal end of the compression device, at 14. The loading devicedefines a lumen having a perimeter that is substantially similar to (i)the perimeter of the lumen at the distal end of the compression deviceand (ii) a perimeter of a lumen of the delivery catheter. As describedabove, the valve can be pushed and/or pulled through the compressiondevice and into the loading device. Moreover, the perimeter of the lumenof the loading device is such that the valve is in the deliveryconfiguration when disposed in the lumen of the loading device. With thevalve compressed to the compressed and/or delivery configuration, thevalve is ready to be advanced, for example, into and/or through thedelivery catheter and into a target location in the patient (e.g., anannulus of a native heart valve).

FIG. 66 is a flowchart illustrating a method 20 of preparing aprosthetic valve for side-delivery to a patient via a delivery catheter,according to an embodiment. The valve can be substantially similar toany of those described herein such as the valves 100, 400, 500, 600,700, 800, and/or 1000 and/or any of those described in the '957 PCT, the'010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327Provisional, the '964 Provisional, the '345 Provisional, and/or the '807Provisional incorporated by reference herein. For example, the valve caninclude an outer support frame and an (inner) flow control componentthat is mounted in and/or to the outer support frame. The outer supportframe can include, for example, a supra-annular member or region, asubannular member or region, and a transannular member or region coupledtherebetween. The flow control component is mounted to the outer supportframe such that is extends through a portion of the transannular memberor region, as described above. Moreover, the valve is compressible alonga central axis parallel to a fluid flow direction through the valve anda lateral axis orthogonal and/or perpendicular to the central axis.

The method 20 includes compressing the prosthetic valve along thelateral axis of the valve perpendicular to the central axis, at 21. Insome implementations, the valve is manually compressed along the lateralaxis. For example, a user can exert a lateral force on the valve tocompress, fold, and/or squeeze the valve into a laterally compressedconfiguration.

After laterally compressing the valve, the valve is inserted into aproximal end of a compression device that defines a lumen extendingthrough the proximal end and a distal end, at 22. In some embodiments, aperimeter of the lumen at the proximal end is larger than a perimeter ofthe lumen at the distal end as described above with reference to thecompression device 1090. Moreover, in some implementations, the valvecan be inserted into the compression device while that the compressiondevice and the valve are disposed in a fluid bath (e.g., a saline bathor the like). As described above, a distal end of the valve can beinserted into the compression device prior to a proximal end of thevalve (e.g., a distal anchoring element can lead the valve through thecompression device).

The prosthetic valve is pulled through the lumen of the compressiondevice and into a loading device coupled to the compression device via atether attached to a distal end portion of the valve such that the valveis compressed along the central axis to place the prosthetic valve in adelivery configuration when in the lumen of the loading device, at 23.In some embodiments, the tether can be included in a pulling device thatis removably coupled to a distal end of the loading device. For example,the pulling device can be and/or can include a spool and/or windingdevice about which a portion of the tether is spooled or wound. In suchembodiments, rotating the spool, winding, and/or any other suitableportion of the pulling device can increase a tension along the tetherthat can pull the tether through the compression device and into theloading device. As described in detail above, the compression device canhave and/or can define a tapered lumen with a distal end thereofcorresponding to a size of the valve in the delivery configuration. Thelumen of the loading device can be substantially similar to the lumen atthe distal end of the compression device and thus, the valve is in thedelivery configuration when pulled into the lumen of the loading device.

The tether is removed from the distal end portion of the prostheticvalve, at 24. For example, the tether can be part of a pulling deviceand/or the like as described above, which in turn, can be decoupled fromthe distal end of the loading device. In some implementations, a usercan, for example, pull on one end of the tether to withdraw the tetherfrom the distal end portion the valve and the loading device. Moreover,the arrangement of the tether and valve is such that the tether can beremoved from the distal end portion of the valve while the valve is inthe delivery configuration and disposed in the lumen of the loadingdevice.

The distal end of the loading device is coupled to a delivery deviceincluding the delivery catheter, at 25. The delivery device can be anysuitable device such as, for example, the delivery device 1081 describedabove with reference to FIGS. 24-39. As such, the delivery device caninclude a handle and/or proximal portion that is coupled to the distalend of the loading device while the delivery catheter extends distallytherefrom. In some implementations, at least one of the lumen of theloading device or the lumen of the delivery device can be flushed whenthe loading device is coupled to the delivery device and prior toadvancing the valve from the loading device into the delivery device. Insome implementations, the loading device and the delivery device caneach include a gate or the like that is in a closed state until aflushing procedure has been performed and, after flushing, the gates canbe transitioned to an open state to allow the valve to be transferredfrom the loading device into the delivery device for side-delivery viathe delivery catheter.

FIG. 67 is a flowchart illustrating a method 30 of preparing aprosthetic valve for side-delivery to a patient through a lumen of adelivery catheter included in a delivery device, according to anembodiment. The valve can be substantially similar to any of thosedescribed herein such as the valves 100, 400, 500, 600, 700, 800, and/or1000 and/or any of those described in the '957 PCT, the '010 PCT, the'231 PCT, the '390 PCT, the '108 PCT, the '327 Provisional, the '964Provisional, the '345 Provisional, and/or the '807 Provisionalincorporated by reference herein. For example, the valve can include anouter support frame and an (inner) flow control component that ismounted in and/or to the outer support frame. The outer support framecan include, for example, a supra-annular member or region, a subannularmember or region, and a transannular member or region coupledtherebetween. The flow control component is mounted to the outer supportframe such that is extends through a portion of the transannular memberor region, as described above. Moreover, the valve is compressible alonga central axis parallel to a fluid flow direction through the valve anda lateral axis orthogonal and/or perpendicular to the central axis.

The method 30 includes compressing the prosthetic valve along thecentral axis and the lateral axis to transition the valve from anexpanded configuration to a delivery configuration, at 31. In someimplementations, the valve is manually compressed along the lateralaxis. For example, a user can exert a lateral force on the valve tocompress, fold, and/or squeeze the valve into a laterally compressedconfiguration. In some implementations, after laterally compressing thevalve, the valve is advanced through a compression device to compressthe valve along the central axis. In other implementations, the valvecan be advanced through a compression device without manuallycompressing the valve along the lateral axis. For example, a first endof a compression device can have a size sufficient to receive anuncompressed valve and advancing the valve therethrough compresses thevalve laterally and axially. In some implementations, the compressiondevice can have an inner surface that defines a lumen and the size,shape, and/or configuration of the inner surface can at least partiallydefine the way the valve is compressed as the valve is advancedtherethrough. Moreover, a size and/or shape of the inner surface orlumen at a second end (e.g., a distal end) can be associated with asize, shape, and/or axial-lateral extent of the valve in the deliveryconfiguration. Thus, the valve is transitioned from the expandedconfiguration to a delivery configuration.

The valve in the delivery configuration is advanced into a lumen of aloading device while a first gate at a distal end of the loading deviceis in a closed state to at least partially occlude the lumen of theloading device, at 32. For example, in some embodiments, the valve canbe advanced through a compression device to be placed in the deliveryconfiguration and then advanced into the lumen of the loading device, asdescribed in detail above. In some implementations, the valve can beadvanced into the lumen of the loading device to place a distal end or adistal subannular anchoring element in contact with and/or adjacent to aproximal side of the gate in the closed state. In some implementations,a hemostasis valve or the like can be coupled to the proximal end of theloading device when the valve is disposed therein to substantially sealthe proximal end, with the prosthetic valve being disposed between thegate in the closed state and the hemostasis valve.

A distal end of the loading device is coupled to a handle of thedelivery device while (i) the first gate is in the closed state and (ii)while a second gate at a proximal end of the handle is in a closed stateto at least partially occlude a lumen of the handle, at 33. The lumen ofthe delivery catheter is in fluid communication with the lumen of thehandle distal to the second gate. In some instances, a volumecollectively defined by the lumens of the loading device and thedelivery device between the first gate in the closed state and thesecond gate state can be flushed while the valve is proximal to thefirst gate. Each of the first gate and the second gate are transitionedfrom the closed state to an open state, at 34. For example, in someimplementations, the gates are transitioned after flushing and/or thelike. In some implementations, the gates can be opened in asubstantially concurrent process. In other implementations, the firstgate can be transitioned to the open state prior to the second gate, orvice versa. Moreover, transitioning the gates from the closed state tothe open state can allow the valve to be advanced from the loadingdevice and into a lumen of the delivery catheter for side-delivery ofthe valve to a target location in the patient (e.g., an annulus of anative heart valve).

FIG. 68 is a flowchart illustrating a method 40 of using a controldevice to selectively control a side-deliverable transcatheterprosthetic valve during at least one of delivery and deployment,according to an embodiment. The valve can be substantially similar toany of those described herein such as the valves 100, 400, 500, 600,700, 800, and/or 1000 and/or any of those described in the '957 PCT, the'010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327Provisional, the '964 Provisional, the '345 Provisional, and/or the '807Provisional incorporated by reference herein. For example, the valve caninclude an outer support frame and an (inner) flow control componentthat is mounted in and/or to the outer support frame. The outer supportframe can include, for example, a supra-annular member or region, asubannular member or region, and a transannular member or region coupledtherebetween. The flow control component is mounted to the outer supportframe such that is extends through a portion of the transannular memberor region, as described above. Moreover, the valve is compressible alonga central axis parallel to a fluid flow direction through the valve anda lateral axis orthogonal and/or perpendicular to the central axis.

The control device can be any suitable control device, actuator,delivery and/or retrieval system, and/or the like. For example, in someimplementations, the control device can include at least a controlcatheter having a first tether, a second tether, and a tension memberextending therethrough, and a yoke coupled to a distal end of thecontrol catheter. In some embodiments, the control device can be similarto and/or substantially the same as the control devices 970 and/or 1070described in detail above.

The method 40 includes increasing a tension along the first tether andthe second tether to secure the yoke against a surface of the prostheticvalve, at 41. As described above with reference to the control device1070, the first tether and the second tether can be looped through afirst portion and a second portion of the yoke, respectively, and afirst attachment point and a second attachment point on the valve,respectively, to removably couple the yoke to the surface of the valve.

The valve is advanced through a lumen of a delivery catheter while theyoke is secured against the surface of the prosthetic valve, at 42. Forexample, in some implementations, a user and/or operator can exert adistally directed force on the control device and with the yoke securedagainst the surface of the valve, the control device can push the valvethrough the lumen of the delivery device (e.g., via a yoke-valveinterface). In other implementations, the control device can include apusher or the like that can extend through a portion of the valve toengage and/or contact a distal subannular anchoring element. As such,the distally directed force can be exerted on the distal subannularanchoring element, which in turn, can be operable to pull the valvethrough the lumen of the delivery catheter. In either implementation,when the valve reaches the distal end of the delivery catheter, valve isreleased from the distal end of the delivery catheter, at 43.

After releasing the valve, a tension along the tension member isincreased to transition a proximal subannular anchoring element from afirst configuration to a second configuration, at 44. For example, insome implementations, the arrangement of the control device and valvecan be similar to and/or substantially the same as the arrangementdescribed above with reference to the valves 600, 700, 800, and/or 1000.In some implementations, for example, the tension along the tensionmember can pull the proximal subannular anchoring element in asupra-annular direction toward the supra-annular region of the valve. Inother implementations, the tension along the tension member can causethe proximal subannular anchoring element (or at least a portionthereof) to swing in one of an anterior direction or a posteriordirection. As such, increasing the tension along the tension member canreduce reconfigure the proximal subannular anchoring element to, forexample, reduce a perimeter of the subannular region of the valve.

The prosthetic valve is seated in an annulus of a native valve inresponse to a force exerted by the yoke on the surface of the prostheticvalve, at 45. For example, as described above, the yoke can be removablysecured to a surface of the valve such that a distally directed forceexerted on a proximal end of the control device results in the yokeexerting at least a portion of the distally directed force on thesurface of the valve. In some implementations, a distal end of thecontrol device can be steerable or the like such that at least a portionof the force exerted on the valve is in a subannular direction. In someimplementations, the increasing the tension along the tension membercan, for example, be operable to bow, bend, steer, deflect, and/orelastically (e.g., non-permanently) deform the distal end of the controldevice such that a distally directed force exerted along the controldevice results in the yoke exerting at least a portion of the force inthe subannular direction, as described in detail above with reference tothe control device 1070 shown in FIG. 34B.

The tension along the tension member is released to allow the proximalsubannular anchoring element to transition from the second configurationtoward the first configuration after the seating the prosthetic valve,at 46. For example, as described above with reference to the valves 600,700, 800, and/or 1000, the proximal anchoring element can be configuredto transition between the first configuration and the secondconfiguration. The proximal anchoring element can be placed in thesecond configuration to reduce a perimeter of at least the subannularregion of the valve as the valve is seated in the annulus. Once seated,the proximal anchoring element can be allowed to transition from thesecond configuration to the first configuration (e.g., an expandedconfiguration) to at least partially secure the valve in the annulus. Insome instances, releasing the tension along the tension members canallow the proximal anchoring element to automatically transition fromthe second configuration to or toward the first configuration.

Once the valve is seated in the annulus, the control device is decoupledfrom the prosthetic valve, at 47. For example, as described above withreference to the valve 1000 and the control device 1070, the yoke can bereleasably coupled to the valve via the tethers. The arrangement of thetethers can be such that pulling on one of a proximal end or a distalend of the tethers is operable to withdraw the tethers from the yoke andthe attachment points of the valve. Thus, the yoke can be decoupled fromthe valve. Similarly, the tension member can be coupled to the proximalanchoring element in such a releasable manner. Accordingly, decouplingthe control device from the valve can include releasing and withdrawingthe tethers and the tension member. In addition, the guidewire cathetercan be retracted from the valve. The control device can then beretracted through the delivery catheter while the valve remains seatedin the annulus.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Likewise, it should be understood that the specificterminology used herein is for the purpose of describing particularembodiments and/or features or components thereof and is not intended tobe limiting. Various modifications, changes, and/or variations in formand/or detail may be made without departing from the scope of thedisclosure and/or without altering the function and/or advantagesthereof unless expressly stated otherwise. Functionally equivalentembodiments, implementations, and/or methods, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions and are intended to fall within the scope of thedisclosure.

Where schematics, embodiments, and/or implementations described aboveindicate certain components arranged in certain orientations orpositions, the arrangement of components may be modified. Althoughvarious embodiments have been described as having particular featuresand/or combinations of components, other embodiments are possible havinga combination of any features and/or components from any of embodimentsdescribed herein, except mutually exclusive combinations. Theembodiments described herein can include various combinations and/orsub-combinations of the functions, components, and/or features of thedifferent embodiments described.

Where methods described above indicate certain events occurring incertain order, the ordering of certain events may be modified.Additionally, certain of the events may be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. While methods have been described as having particularsteps and/or combinations of steps, other methods are possible having acombination of any steps from any of methods described herein, exceptmutually exclusive combinations and/or unless the context clearly statesotherwise.

1.-93. (canceled)
 94. A delivery and retrieval system for aside-deliverable prosthetic valve, the system comprising: a catheterhaving a distal end and defining a lumen, the prosthetic valve having adelivery configuration for side delivery through the lumen of thecatheter and a deployment configuration when released from the distalend of the catheter; a capture element disposable in the lumen of thecatheter in a closed configuration and transitionable to an openconfiguration when advanced beyond the distal end of the catheter; and acontrol device disposable in the lumen of the catheter and configured toattach to the prosthetic valve, the control device operable to (i) exerta distally directed force to advance the prosthetic valve in thedelivery configuration through the lumen of the catheter and (ii) exerta proximally directed force to pull the prosthetic valve in thedeployment configuration into the distal end of the catheter, thecapture element extendable around at least a portion of the prostheticvalve to transition the prosthetic valve from the deploymentconfiguration to the delivery configuration as the control device pullsthe prosthetic valve into the distal end of the catheter.
 95. The systemof claim 94, wherein the capture element is a self-expanding captureelement formed from a shape-memory alloy.
 96. The system of claim 94,wherein the catheter is an outer catheter, the capture element ismounted at a distal end of an inner catheter movably disposed in thelumen of the catheter.
 97. The system of claim 94, wherein the captureelement is mounted within the lumen of the catheter and istransitionable to the open configuration by withdrawing a slidablesheath at the distal end of the catheter.
 98. The system of claim 94,wherein the capture element is mounted at a distal end portion of thecontrol device.
 99. The system of claim 94, wherein the control deviceincludes a yoke configured to removably contact a surface of theprosthetic valve.
 100. A retrieval system for a side-deliverableprosthetic valve, the system comprising: a control device removablycoupleable to the prosthetic valve during delivery and deployment of theprosthetic valve in an annulus of a native valve; and a self-expandingcapture element that is extendable from a distal end of a deliverycatheter to funnel or wrap at least a portion of the prosthetic valve atleast partially deployed in an annulus of a native heart valve tofacilitate a compression of the prosthetic valve in response to a forceexerted by the control device moving the prosthetic valve in a proximaldirection toward the delivery catheter.
 101. The system of claim 100,wherein the control device includes a yoke configured to removablycontact a surface of the prosthetic valve.
 102. The system of claim 100,wherein the prosthetic valve has a delivery configuration and adeployment configuration, the compression of the prosthetic valve beingoperable to at least partially transition the prosthetic valve from thedeployment configuration to the delivery configuration.
 103. The systemof claim 102, wherein the self-expanding capture element facilitates thecompression of the prosthetic valve to the delivery configuration suchthat the force exerted by the control device pulls the prosthetic valvein the delivery configuration into the delivery catheter.
 104. A methodof retrieving a side-deliverable prosthetic heart valve, comprising: (i)extending a self-expanding capture element from a distal end of acatheter disposed in a native atrium of a heart, the capture elementconfigured to have a cavity shape when in an extended position; and (ii)pulling the heart valve into the cavity of the extended capture elementto facilitate compressing of the heart valve, wherein pulling the heartvalve into the capture element transitions the capture element from theextended position to a retracted position, wherein the heart valve iswrapped by the capture element in the retracted position, and whereinthe heart valve that is wrapped by the capture element is pulled intothe catheter using a cable.
 105. The method of claim 104, wherein thevalve is pre-compressed by (a) suturing the proximal tab against theunderside of the atrial collar, or (b) pinching the proximal sidewallhips, or (c) both, prior to pulling the heart valve into the cavity.106. The method of claim 105, wherein a yoke element on the cable isused to suture the proximal tab, pinch the sidewall hips, or both.